Class I - Dangerous
Product contains particulates (fibers)
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
Product contains particulates (fibers)
Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Class I - Dangerous
The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
Class I - Dangerous
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Roche Diagnostics Operations
Class I - Dangerous
Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Philips Healthcare
Class I - Dangerous
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,
Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Class I - Dangerous
These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot