Recall Z-0016-2026 ยท MEC Disinfector, Medical Devices
Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
| Date | Oct 1, 2025 (initiated Aug 29, 2025) |
| Status | Open, Classified |
| Reason | Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. |
| Root cause | Under Investigation by firm |
| Action | Getinge notified consignees on about 08/29/2025 via letter. Consignees were instructed that Getinge service technicians will be proactively reaching out to ensure affected devices are calibrated appropriately. In the meantime, Getinge has developed a verification procedure to ensure that the circulation pressure in standby mode is correctly calibrated to 0.0 kPa. If the value deviates, recalibration by a qualified technician is required. The verification of the circulation pressure shall be performed by the operator or Getinge technician. If the value deviates from 0.0 kPa out of allowed toler |
| Quantity | 902 units |
| Distribution | Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.