2012 Product Recalls
5,173 recalls issued in 2012.
Showing 4981–5000 of 5,173 recalls
Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects
Failure to provide the complete User Manual information.
A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.
GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in
GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.
ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.
Consignees were sent a TomoTherapy "Urgent Field Safety Notice" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone.
GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine,
GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the g
GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 yard rolls (CAT #1530-1) as a substitutio
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.
GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.
SERVICE BRAKES/ANTILOCK TRACTION RELAY VALVE
INADVERTENT BRAKE APPLICATION CAN CAUSE THE BRAKES TO OVERHEAT AND LEAD TO A FIRE. INADVERTENT BRAKE APPLICATION CAN CAUSE THE WHEELS TO LOCK-UP LEADING THE DRIVER TO LOSE CONTROL OF THE VEHICLE, INCREASING THE RISK OF A CRASH.
MACK WILL NOTIFY OWNERS, AND PROVIDE A TEMPORARY REPAIR UNTIL BENDIX DEVELOPS A PERMANENT REMEDY. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. OWNERS MAY CONTACT MACK TRUCKS AT 1-800-866-1177.
SERVICE BRAKES/ANTILOCK TRACTION RELAY VALVE
INADVERTENT BRAKE APPLICATION CAN CAUSE THE BRAKES TO OVERHEAT AND LEAD TO A FIRE. INADVERTENT BRAKE APPLICATION CAN CAUSE THE WHEELS TO LOCK-UP LEADING THE DRIVER TO LOSE CONTROL OF THE VEHICLE, INCREASING THE RISK OF A CRASH.
VOLVO WILL NOTIFY OWNERS, AND PROVIDE A TEMPORARY REPAIR UNTIL BENDIX DEVELOPS A PERMANENT REMEDY. A PERMANENT REMEDY HAS BEEN DEVELOPED AND NOTIFICATION TO OWNERS BEGAN ON APRIL 27, 2012. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. OWNERS MAY CONTACT VOLVO TRUCKS AT 1-800-528-6586.
WHEELCHAIR LIFT/OUTER ROLL STOP LATCHING MECHANISM
A WHEELCHAIR OCCUPANT MAY DEFEAT OR RIDE OVER THE INSUFFICIENTLY LATCHED ROLL STOP. IF THIS OCCURS WHEN THE LIFT PLATFORM IS IN AN ELEVATED POSITION, THE WHEELCHAIR'S OCCUPANT COULD FALL AND SUSTAIN INJURY.
BRAUN WILL NOTIFY OWNERS, AND DEALERS WILL REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 30, 2012. OWNERS MAY CONTACT BRAUN CUSTOMER SERVICE CENTER AT 1-800-488-0359.
PRNDL CABLE
AN INCORRECT GEAR INDICATION IN THE INSTRUMENT PANEL MAY PREVENT THE DRIVER FROM KNOWING IF THEY ARE IN PARK OR REVERSE, INCREASING THE RISK OF A CRASH.
FORD WILL NOTIFY OWNERS AND DEALERS WILL REPLACE THE TRANSMISSION SELECTOR ARM ASSEMBLY AND THE PRNDL CABLE ASSEMBLY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 2, 2012. OWNERS MAY CONTACT FORD MOTOR COMPANY CUSTOMER RELATIONSHIP CENTER AT 1-866-436-7332.
Coleman, Coleman Evcon and Red T Gas Furnaces for Manuf Recalled for Fire Hazard
The furnace can overheat and cause the heat-exchanger to crack and create openings that allow flames to be exposed. When this happens, drywall and other nearby combustibles are exposed to the flames, posing a fire and smoke hazard to consumers.
Consumers should immediately stop using the furnace until it has been inspected and repaired. Consumers should contact UPG to schedule a free inspection and repair of any furnace involved in the recall.
Carter's Watch the Wear Bodysuits and Sleep 'n Play Gar Recalled for Choking Hazard
The snaps can detach from the fabric of the garment, posing a choking hazard to infants and young children.
Consumers should immediately discontinue use of garments and contact Weeplay to receive free replacement garments.
Bumbleride Indie & Indie Twin Strollers Recalled for Fall Hazard
The front wheel can break at the axle hub, causing the stroller to tip and posing a fall hazard.
Consumers should immediately stop using the recalled strollers and contact Bumbleride to receive a free front wheel retrofit kit.
2ND ROW HEAD RESTRAINT SUPPORT BRACKETS/FMVSS 202
IN THE EVENT OF A CRASH, THE SEAT HEAD RESTRAINT MAY NOT PROVIDE THE REQUIRED STRENGTH, INCREASING THE RISK OF INJURY.
FORD WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE HEAD RESTRAINTS AS NECESSARY, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 21, 2012. OWNERS MAY CONTACT FORD MOTOR COMPANY CUSTOMER RELATIONSHIP CENTER AT 1-866-436-7332.
HP fax 1040 and 1050 machines Recalled for Fire Hazard
The fax machines can overheat due to an internal electrical component failure, posing fire and burn hazards.
Consumers should immediately stop using the recalled fax machines, disconnect them from the electrical outlet and contact HP for a rebate on the purchase of an authorized replacement HP fax machine or a partial rebate of certain HP ink jet printers.
Fold-Out Sleeper Ottomans Recalled for Fall Hazard
The welding joints on the legs can break, posing a fall hazard to consumers.
Consumers should immediately stop using the product and contact the firm to obtain instructions on how to obtain a full refund. LTD Commodities is directly notifying known purchasers about the recall.
Overarching Floor Lamp Recalled for Shock Hazard
A short circuit can occur in the lamp's wiring, posing a shock hazard to consumers.
Consumers should immediately stop using the lamp and return it to West Elm for a full store credit.
Konica Minolta Printers Recalled for Fire Hazard
The printers can short circuit and overheat during use, posing a fire hazard.
Consumers of Magicolor 3730DN and 4750DN should stop using the printers immediately and contact Konica Minolta to schedule a free replacement. Consumers of Bizhub C35 and C35P will be visited by an authorized service agent for repair and replacement of the faulty component.
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.
Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.
VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. Intended for the percent determination of hemoglobin A1c in huma
It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114.