Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal d

FDA device recall Z-2079-2012 · posted 2012-07-26 · Terminated

Recall details

Recalling firm

Getinge USA Inc

Reason for recall

Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.

Action taken

Getinge USA issued a Device Correction Notice dated June 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to perform a trip test to determine if they have a functioning ground fault breaker. Customers will be contacted by a Getinge representative to schedule an appointment to exchange the earth fault breaker. Customers were provided a Customer Response Form to complete and fax back to 585-272-5033. For questions customers should call 800-475-9040, ext. 5270. For questions regarding this recall call 585-475-1400.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MEC

Quantity affected

8 washers

Distribution

Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada

Date initiated

2012-05-25

Date posted

2012-07-26

Date terminated

2016-05-18

Location

Rochester, NY