Recall Z-0852-2015 ยท MEC Disinfector, Medical Devices
Getinge Disinfection Ab
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
| Date | Dec 23, 2014 (initiated Nov 26, 2014) |
| Status | Terminated |
| Reason | Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur. |
| Root cause | Device Design |
| Action | An Urgent Field Safety Notice was sent to consignees in North America via USPS Certified Mail with signature receipt on 11/25/14 informing them of the correction. The actions that will be carried out will fully address the problem of sedimentation i.e. stop any future sedimentation. You will be contacted by a Getinge representative to schedule a visit. No additional precautions need to be taken by the end user until the Getinge representative arrives. For questions, please contact Getinge USA at 1-800-320-3532. |
| Quantity | 551 total: USA: 547 units, Canada: 4 units |
| Distribution | Distributed US (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.