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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Medical Systems

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  Class 2 Device Recall Maquet Medical Systems see related information
Date Initiated by Firm August 21, 2014
Date Posted January 16, 2015
Recall Status1 Terminated 3 on November 17, 2015
Recall Number Z-0993-2015
Recall Event ID 69560
Product Classification Medical device data system - Product Code OUG
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.
Code Information part number: 1703.35AO, with software version up to 2.1.x.x.
Recalling Firm/
Manufacturer		 Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Mr. Josefino Cabinian
973-709-7000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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