TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as t

FDA device recall Z-0993-2015 · posted 2015-01-16 · Terminated

Recall details

Recalling firm

Maquet Medical Systems USA

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

OUG

Quantity affected

6 units

Distribution

US Nationwide Distribution including NE, NY and PA.

Date initiated

2014-08-21

Date posted

2015-01-16

Date terminated

2015-11-17

Location

Wayne, NJ