🏥 Medical Devices Class I - Dangerous
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Stryker
🏥 Medical Devices Class I - Dangerous
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
🏥 Medical Devices Class I - Dangerous
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
🏥 Medical Devices Class I - Dangerous
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
🏥 Medical Devices Class I - Dangerous
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Murata Vios
🏥 Medical Devices Class I - Dangerous
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
🏥 Medical Devices Class I - Dangerous
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
🏥 Medical Devices Class I - Dangerous
Device reaching End of Service prematurely.
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
HF Acquisition Co
🏥 Medical Devices Class I - Dangerous
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Getinge Usa Sales
🏥 Medical Devices Class I - Dangerous
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
🏥 Medical Devices Class I - Dangerous
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
🏥 Medical Devices Class I - Dangerous
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
🏥 Medical Devices Class I - Dangerous
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.