Z-0993-2015Class II

TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to...

Name: Z-0993-2015 TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to...
Creator: Maquet Medical Systems USA
Published: 2014-08-21
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2014-08-21 / Terminated / root cause: software

FDA source

Maquet Medical Systems USA began a recall of TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an... on 2014-08-21. FDA classified it as Class II and gives the reason as "The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0993-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-21
Posted: 2015-01-16
Terminated: 2015-11-17
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.
Product code: OUG Medical Device Data System
Reason for recall: The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Maquet sent an Urgent Medical Device Field Correction Letter dated August 21, 2014, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following measures until the issue is corrected: The TEGRIS equipped with a software module version up to 2.1.X.X should not be used in conjunction wiht a MAGNUS operating table system. All other MAQUET operating tables are not affected. A MAQUET service representative would contact them and arrange to have their TEGRIS software module updated. Customers with questions were instructed to contact MAQUET Technical Support at 1-888-627-8383 (press option 3, followed by option 1, then option 1 again. For questions regarding this recall call 973-709-7000.
Quantity in commerce: 6 units
Distribution: US Nationwide Distribution including NE, NY and PA.
Product codes and lots: part number: 1703.35AO, with software version up to 2.1.x.x.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0993-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-16

Product code OUG

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)