GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Clas

FDA device recall Z-0852-2015 · posted 2014-12-23 · Terminated

Recall details

Recalling firm

Getinge Disinfection Ab

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MEC

Quantity affected

551 total: USA: 547 units, Canada: 4 units

Distribution

Distributed US (nationwide) and the country of Canada.

Date initiated

2014-11-26

Date posted

2014-12-23

Date terminated

2017-05-12

Location

Vaxjo, Sweden