Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
SARS-CoV-2 Antigen Test
Qiagen Sciences
Class I - Dangerous
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Class I - Dangerous
Recalled products do not have FDA approval for sale in the United States.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
The Magstim Company Limited
Class I - Dangerous
A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Dirty Lens May Cause Invalid or False Positive Results
Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Philips North America
Class I - Dangerous
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Class I - Dangerous
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Class I - Dangerous
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Medline Industries
Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.