Model: TSX-301 CI6A with system software V7.0 SPOO04J
It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile   Orthopaedic Bone Screw
Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification.  As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternative locking screw from the instrumentation set to ensure a fully locked plate and screw construct.
US Distribution to states of: MA, MO, OH, PA, UT, and WI.
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration].  The update contains several important safety and performance fixes.
US: AL, CO, GA, IL IN,  IA, KS, MI, MN, MO, NE, NC, OH, OK, PA, SD, TX, VA WI, WY.
Caribou Chocolate Chip Toffee Pecan Biscotti, Net Wt. 1.4 oz. (40g) in clear cello flow wrap bag.
SKU 012963, All code dates, all use by dates
Biscotti Almond and Biscotti Chocolate Chip Toffee Pecan are being recalled because they are labeled inadequately.  Soy lecithin, a sub-ingredient, was missing from the ingredient list.
Caribou Almond Biscotti, Net Wt. 1.4 oz. (40g) in clear cello flow wrap bag.
SKU 012964, All code dates, all use by dates
Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA.  The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.
Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand  and  Viet Nam.
Access Free T3 Reagent Kit, P/N A13422   The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1)  Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processing  coupled to Twin Beam examinations. 5) Correction to assure proper communication between system components. 6) Correction to improve robustness of ECG triggering.
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains  vials Lidocaine HCl (1%)
Worldwide Distribution - US including AL; AZ; CA; CO; CT; DC; FL; GA; HI; IA; IL; IN; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; NE; NH; NJ; NV; NY; OH; OR; PA; RI; SC; TN; TX; UT; VA; VT; WA; WI; and WV and Internationally to  ARGENTINA; AUSTRALIA; AUSTRIA; BELGIUM; BRAZIL; CANADA; CHILE; COLOMBIA; CZECH REPUBLIC; EGYPT; FRANCE; GERMANY; GREECE; INDIA; ISRAEL; ITALY; KOREA; Mexico; NEW ZEALAND; NORWAY; P R CHINA; PANAMA; PERU; POLAND; RUSSIA; SINGAPORE; SLOVENIA; SOUTH AFRICA; SWITZERLAND; UAE; UK; URUGUAY; VENEZUELA; and VIETNAM.
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C. SIGMA Specialist 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C. SIGMA Specialist  2 (SP2 / SPII) Revision Knee Instruments, and P.F.C.  SIGMA High Performance (HP) Primary Knee Instruments
DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the  Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plates).
Blood and Blood Products for Reprocessing
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
SOMATOM Force; computed tomography x-ray system.   Intended to generate and process cross-sectional images of patients.
Platelet products, which were labeled with the incorrect volumes, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
The American National Red Cross - Southern Region
Worldwide distribution -- US, Canada, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the Netherlands.
Disposable Paper Filter for Sterilization Containers   Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Part Number:   29-10911 Disposable Paper Filter for Sterilization Container, 30x29cm, new type (P/100);   29-10912 Disposable Paper Filter for Sterilization Container, 60x 29cm, old type (P/100), obsolete (Part not distributed in the US);   29-10913 Dispoable Paper Filter for Sterilization Container, 60x29cm new type (P/100)  (Part not distributed in the US);   29-10915 Disposable Paper Filter, 4-holes, for Coiner (Part not distributed in the US)
Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only.  Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5552-3.
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
NY,TX, OK, OR, LA, KS, IN. MO, HI, CA, UT, MI, AZ.
organic girl - good clean greens baby spinach - tender nutrition baby leaves. Washed 3 times. USDA Organic. 5 oz.. plastic clamshell.    Distributed by organic girl, Salinas, CA 93901
use-by September 13, Lot code B030298-001B08S.
Detection of elevated level of Cadmium in the product.
Worldwide Distribution - US Nationwide and the countries of  Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and Uruguay.
MICroSTREP plus 1 Panel, Part No. B1027-201   Product Usage:  MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
MICroSTREP plus 2 Panel, Part No. B1027-202   Product Usage:  MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
Blood product, which was stored at an unacceptable temperature, was distributed.
Blood products, collected on instruments for which there was no documentation of quality control, were distributed.
Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of:  Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1
Images may be missing when a system parameter MapRoute is set to a value greater than 1.
W398515014161H (triple collection); W3985150590380 (triple collection); W3985150590372 (triple collection)
Blood products, with a low platelet yield, were distributed.
Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
Monaco Radiation Treatment Planning System.   Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
GA, MD, KY, AL, NC, VA, TX, TN, NJ, FL, MS, IA
Blue Plate(R) LIGHT MAYONNAISE, 18 Fl OZ (1 PT 2 OZ) 532, mL. UPC 47900-50638
One lot of Blue Plate Light Mayonnaise has the Blue Plate Mayonnaise ingredient statement and nutrition facts on the rear panel.
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Models:  Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces      Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536
small puncture marks in a sterile package for an accessory to an Olympus device
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Medical Device Identification Card for SureScan pacemaker patients.          The front of this card identifies the implanted pacing system components currently registered to the patient.  The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable.  This card is provided to the patient by Medtronic after device registration.
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance  (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
Diabetes Corporation of America dba DCA Pharmacy
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, 233 Bedford Way, Franklin, TN 37064-5527
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Cascadian Farm Organic Cut Green Beans, Net. Wt. 16 oz.
General Mills is recalling a limited quantity of frozen Cascadian Farm Cut Green Beans after one package of finished product tested positive for the presence of Listeria monocytogenes.