Maquet Magnus Carbon-Fibre Operating Table Top Recall for Brake Defect
Maquet is recalling specific Magnus carbon-fibre operating table tops due to a potential issue with motor brakes for the longitudinal shift and tilt drives.
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 is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems, USA is recalling specific units of the Magnus Carbon-Fibre Table Top (Version 1180.16) used in operating table systems. The recall affects 164 units located in 27 countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East.
The recall was initiated after an investigation into customer complaints identified a potential problem with the motor brakes for the longitudinal shift drive and the tilt drive. The affected table tops were manufactured between February 23, 2010, and February 28, 2012, and distributed between November 11, 2010, and April 6, 2012. Specific affected units include Model # 1180.16F2 (Serial #s 1, 3, 7, & 8), Model # 1180.16F3 (Serial # 1), Model # 1180.16F5 (Serial # 4), and Model # T285.7000 (Serial #s 1, 2, 3, 4, & 7).
This is an FDA Class II recall, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote. The source text does not report any injuries or illnesses associated with this defect. Healthcare facilities should contact Maquet Medical Systems for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Maquet Medical Systems, Usa
- Category
- Medical Device — Operating Table
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 (10)
- 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
- 4
- & 7.
Distribution
Distributed nationwide across the United States.
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