Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 265–276 of 426 recalls
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications.…
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially lea…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid…
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L.…
Potential for external cassette leaks
Potential for external cassette leaks