Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue
Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.
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 risk-of-harm product where the mechanism for injury is described, but the source text does not explicitly report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 13 YUNO mobile operating tables and 24 extension devices. The recall addresses a potential issue with the extension device handle (part number 1433.62A1) and includes enhancements to the YUNO table (part number 1433.01F0).
The identified issue occurs when the lever of the extension device handle is fully actuated. In this position, an operator's skin can enter a gap between the handle lever and a recess in the handle bar. The source text notes that the hazard occurs when the lever is released.
The affected products were distributed worldwide, including in the United States (Arizona, Georgia, North Dakota, South Carolina, Texas, and Tennessee) and internationally to the United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa. Users should contact Maquet for information regarding the recall and necessary enhancements.
The recalled product
- Product
- MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
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 (1)
- YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
Distribution
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