Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage:

FDA device recall Z-0989-2019 · posted 2019-03-07 · Terminated

Recall details

Recalling firm

GETINGE US SALES LLC

Reason for recall

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

Action taken

Urgent Medical Device Field Correction notification letters dated 1/8/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Complete and sign the enclosed Customer Response Form (Pages 4 and 5) and return to Getinge using the fax number or email address provided on the form. -A Getinge Service person will contact the person listed on the Customer Response Form (page 5) to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getinge-trained or authorized service technician by calling Getinge Customer Support at (800) 950-9912 (select option 1).

Root cause

Other

Status

Terminated

Product code

FSY

Quantity affected

6

Distribution

The products were distributed to the following US states: AZ and TX.

Date initiated

2019-01-08

Date posted

2019-03-07

Date terminated

2020-06-03

Location

Wayne, NJ