Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 241–252 of 426 recalls
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.