États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesImactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
FDA DevicesBD Alaris" System with Guardrails" Suite MX with Point of Care Unit
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
FDA DevicesHLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA DevicesTandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
FDA DevicesCustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
FDA DevicesFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
FDA FoodKing Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Spinach Hummus 10 oz. UPC 025726 311087
King Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Spinach Hummus 10 oz. UPC 025726 311087
Foreign material (aluminum pieces).
FDA FoodDoraditas de Azucar UPC 5901234123457
Doraditas de Azucar UPC 5901234123457
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy
FDA DevicesPhilips X3-1 Ultrasound Transducer
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA DevicesOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA DevicesPhilips OMNI II TEE Ultrasound Transducer
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA DevicesPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
NHTSAVolkswagen Group of America, Inc. - Sunroof Malfunction/FMVSS 118
Volkswagen Group of America, Inc. - Sunroof Malfunction/FMVSS 118
Closing the sunroof without the ability to see it can increase the risk of injury to occupants.
FDA DevicesPhilips S5-2 Ultrasound Transducer
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA FoodBulk packaged Colustrum Powder. packaged with generic product label.
Bulk packaged Colustrum Powder. packaged with generic product label.
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
FDA DevicesOlympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA DevicesOlympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA FoodKing Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Sundried Tomato Hummus 10 oz. UPC 025726 311186.
King Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Sundried Tomato Hummus 10 oz. UPC 025726 311186.
Foreign material (aluminum pieces).
FDA DevicesOlecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA DevicesEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
NHTSAIsuzu Motors Limited - Improperly Secured Chassis and Cab Wire Harness
Isuzu Motors Limited - Improperly Secured Chassis and Cab Wire Harness
Harness failure may cause an engine stall or the brake lights and parking brake to fail, increasing the risk of a crash. Damaged wires may also melt, increasing the risk of a fire.
NHTSAFord Motor Company - Inoperative Defrosting and Defogging System
Ford Motor Company - Inoperative Defrosting and Defogging System
An inoperative windshield defrosting and defogging system may decrease the driver's visibility, increasing the risk of a crash.
NHTSAFord Motor Company - Incorrectly Installed Piston Circlips
Ford Motor Company - Incorrectly Installed Piston Circlips
An unexpected loss of drive power increases the risk of a crash.
NHTSAFord Motor Company - Front Passenger Air Bag May Not Deploy/FMVSS 208
Ford Motor Company - Front Passenger Air Bag May Not Deploy/FMVSS 208
Failure to correctly detect a passenger may result in the air bag not deploying as intended, increasing the risk of injury during a crash.