🏥 Medical Devices • 6,554 recalls
Beckman Coulter
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
3M Company - Health Care Business
3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
Diagnostica Stago
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
Siemens Healthcare Diagnostics
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Siemens Medical Solutions USA
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Labories Medical Technologies
The packaging may be damaged, compromising the sterile barrier.
Siemens Medical Solutions USA
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
Draeger Medical Systems
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
Due to potential software issue that may result in patient mix-up information.
BioFire Diagnostics
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Ortho-Clinical Diagnostics
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+" solution is indicated for use in the clinical laboratory.
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.