🏥 Medical Devices Class I - Dangerous
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
All Recalls
95,025 total recalls in our database
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
WELCH ALLYN, INC/MORTARA
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
🏥 Medical Devices Class I - Dangerous
An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.
🏥 Medical Devices Class I - Dangerous
During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Vascular Solutions
🏥 Medical Devices Class I - Dangerous
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Avanos Medical
🏥 Medical Devices Class I - Dangerous
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
WELCH ALLYN, INC/MORTARA
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Philips North America
🏥 Medical Devices Class I - Dangerous
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
🏥 Medical Devices Class I - Dangerous
The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.
🏥 Medical Devices Class I - Dangerous
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Ortho Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
🏥 Medical Devices Class I - Dangerous
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
WELCH ALLYN, INC/MORTARA
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
🏥 Medical Devices Class I - Dangerous
No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
WELCH ALLYN, INC/MORTARA
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.