Maquet Tegris System Recalled Due to Software Error in Operating Table Commands
Maquet Medical Systems USA is recalling six units of the Tegris System because a software error switches leg movement commands for the Magnus OR table.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could lead to unintended patient movement during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling six units of the Tegris System, a central operating unit designed for operating rooms. The system is manufactured by MAQUET GMBH in Germany and is used for recording and distributing images and videos, as well as interacting with medical and non-medical devices.
The recall is due to a software error affecting the integration with the MAGNUS operating table system. Specifically, the button commands on the Tegris touchscreen for 'Lower Leg Up' and 'Upper Leg Down' are switched, which results in the wrong movement on the MAGNUS OR table.
The affected units are identified by part number 1703.35AO with software version up to 2.1.x.x. These units were distributed nationwide in the United States, including in New England, New York, and Pennsylvania. Users should stop using the affected software and contact the manufacturer for instructions on correcting the issue.
The recalled product
- 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…
- Manufacturer
- Maquet Medical Systems USA
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- part number: 1703.35AO
- with software version up to 2.1.x.x.
Distribution
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