Maquet Yuno Extension Table Device Recalled for Screw Tension Issue
Maquet Inc. is recalling 63 Yuno Extension Table Devices due to a potential issue with the screw tension of the extension device.
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 structural defect in a medical device used during surgery, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Maquet Inc. is recalling 63 units of the Maquet Yuno Extension Table Device. The recall is due to a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
The device is used to support the lower extremities immediately before, during, and after surgery. It is mounted to the YUNO operating table and is intended to be operated only by medically trained staff within the operating room environment.
The affected devices were distributed worldwide, including in the United States (Arkansas, Georgia, South Carolina, Texas, and Tennessee) and internationally to France, the United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, the United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
The recalled product
- Product
- Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product…
- Manufacturer
- Maquet Inc.
- Category
- Medical Device — Surgical Table
- Hazard
- Affected units
- 63
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)
- Class I exempt Device Listing Number A922956
Distribution
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