Z-0161-2009

Accessory Head Rest for Alphastar Operating Tables

Name: Z-0161-2009 Accessory Head Rest for Alphastar Operating Tables
Creator: MAQUET Inc.
Published: 2008-09-26
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2008-09-26 / Terminated

FDA source

MAQUET Inc. began a recall of Accessory Head Rest for Alphastar Operating Tables on 2008-09-26. The reason FDA records is "During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0161-2009
Status: Terminated
Initiated: 2008-09-26
Posted: 2008-10-16
Terminated: 2009-04-16
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Accessory Head Rest for Alphastar Operating Tables
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.
FDA root cause: Other
Action: Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.
Quantity in commerce: 88 units in US; 1884 units worldwide
Distribution: Nationwide Distribution
Product codes and lots: USA Part Number 1130.67F0, No serial numbers

Product code FQO

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)