Medical device recalls

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis.

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

The firm discovered through customer complaints that device segments may not meet specifications.

The firm discovered through customer complaints that device segments may not meet specifications.

The firm discovered through customer complaints that device segments may not meet specifications.

The firm discovered through customer complaints that device segments may not meet specifications.

There is a software login in issue that may prevent the user from logging in.

There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

Reagent lot numbers include an insufficient concentration of blocking reagent.

There is a software login in issue that may prevent the user from logging in.

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

The test medium may not perform as intended.

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery