Z-0480-2010

Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS...

Name: Z-0480-2010 Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS...
Creator: Maquet Inc.
Published: 2009-10-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2009-10-22 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning... on 2009-10-22. The reason FDA records is "Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0480-2010
Status: Terminated
Initiated: 2009-10-22
Posted: 2009-12-02
Terminated: 2010-05-18
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
Product code: FWZ Operating Room Accessories Table Tray
Reason for recall: Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.
Quantity in commerce: 9 units in US.
Distribution: Nationwide Distribution -- USA, including states of SC and PA.
Product codes and lots: No serial or lot numbers, just a catalogue number.

Product code FWZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)