Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
All Recalls
95,018 total recalls in our database
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Medtronic
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
🏥 Medical Devices Class I - Dangerous
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Medtronic
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Medtronic
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
GE Healthcare Finland Oy
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Dental EZ Group Star Dental Division
🏥 Medical Devices Class I - Dangerous
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Inspire Model 3028, IV Implantable Pulse Generator
Inspire Medical Systems
🏥 Medical Devices Class I - Dangerous
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Medtronic
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
🏥 Medical Devices Class I - Dangerous
Product labels state the incorrect expiration dates that extends beyond their true expiration date
🏥 Medical Devices Class I - Dangerous
Potential for coils to heat up and harm patients (burn).
🏥 Medical Devices Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
🏥 Medical Devices Class I - Dangerous
Product labels state the incorrect expiration dates that extends beyond their true expiration date