Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
- Company
- Getinge Us Sales Llc
- Recall Initiated
- January 8, 2019
- Posted
- March 7, 2019
- Terminated
- June 3, 2020
- Recall Number
- Z-0990-2019
- Quantity
- 4
- Firm Location
- Wayne, NJ
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.
Distribution
The products were distributed to the following US states: AZ and TX.
Lot / Code Info
Serial Numbers 500013 500014 500096 500097
Root Cause
Other
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).