Z-2108-2012Class II

Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre...

Name: Z-2108-2012 Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre...
Creator: Maquet Medical Systems, Usa
Published: 2012-04-13
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2012-04-13 / Terminated / root cause: design

FDA source

Maquet Medical Systems, Usa began a recall of Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and... on 2012-04-13. FDA classified it as Class II and gives the reason as "As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February...". 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-2108-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-13
Posted: 2012-07-30
Terminated: 2013-09-04
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.
Root cause tag: design
FDA root cause: Device Design
Action: MAQUET GETINGE Group sent An "Urgent Device Field Correction" notification, dated 13 April 2012 via Federal Express to all affected customers. An acknowledgement form is included with the customer letter which can be mailed or faxed back to Maquet Quality by the notified customers. If the completed Acknowledgement form is not received within 15 days, up to three follow ups will be made and documented via telephone call to each customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and notify their MAQUET Service Representative immediately. The MAQUET Service Representative will contact customers to make arrangements to replace both te logitudinal shift and tilt drives of their table top(s). For questions customers should call 888-627-8383, press option 2, followed by option 1. For questions regarding this recall call 201-995-8968.
Quantity in commerce: 164 Units located in 27 Countries
Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.
Product codes and lots: Model # 1180.16F2 Serial #s 1,3,7, & 8; Model # 1180.16F3 Serial # 1; Model #1180.16F5 Serial #4; Model # T285.7000 Serial #s 1,2,3,4, & 7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2108-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-30

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)