🏥 Medical Devices Class I - Dangerous
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Potential for the tip of the electrode to detach during use.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
🏥 Medical Devices Class I - Dangerous
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
🏥 Medical Devices Class I - Dangerous
Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Cook Incorporated
🏥 Medical Devices Class I - Dangerous
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
🏥 Medical Devices Class I - Dangerous
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Centricity Radiology RA600
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Centricity Universal Viewer Zero Footprint Client
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Centricity Enterprise Web
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
🏥 Medical Devices Class I - Dangerous
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
🏥 Medical Devices Class I - Dangerous
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
Centricity Cardiology CA1000
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
🏥 Medical Devices Class I - Dangerous
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Centricity PACS RA1000
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.