Z-0990-2019Class II

Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A

Name: Z-0990-2019 Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A
Creator: Getinge US Sales Llc
Published: 2019-01-08
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2019-01-08 / Terminated

FDA source

GETINGE US SALES LLC began a recall of 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... on 2019-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0990-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-08
Posted: 2019-03-07
Terminated: 2020-06-03
Recalling firm: Getinge US Sales LLC
Product: 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.
Product code: FSY Light, Surgical, Ceiling Mounted
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.
FDA root cause: Other
Action: 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).
Quantity in commerce: 4
Distribution: The products were distributed to the following US states: AZ and TX.
Product codes and lots: Serial Numbers 500013 500014 500096 500097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0990-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07
Z-0988-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07
Z-0989-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07
Z-0990-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)