UFSK Treatment Chair 500 XLE Seat Drive Failure Risk
The UFSK Treatment chair 500 XLE's electrical seat drive may wear unexpectedly, causing the chair to fail to hold position while the patient is seated in an inclined position. Healthcare facilities should contact the manufacturer regarding affected units.
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: FDA Class II recall of a patient-positioning medical device where the seat drive may fail to maintain position while inclined. Although no injuries have been reported, the potential for patient harm from unexpected seat movement makes this a risk-of-harm product warranting a High severity score.
Plain-English summary
The UFSK Treatment chair 500 XLE is a medical device used to position and support patients during ophthalmology and other diagnostic or therapeutic treatments. The electrical seat drive in these chairs may experience shortened service life due to wear-related reduction in the self-locking mechanism, which may not be immediately apparent.
Over time, wear in the seat drive's self-locking function can worsen, causing the drive to override its end position when the chair's seat is inclined. This means the seat may not remain securely in place when the patient is positioned at an angle, creating a risk that the seat could move unexpectedly.
The recall affects 239 chairs with serial numbers 2000-2999 (Art.no. 15000004) and 3000-4506 (Art.no. 15000006), distributed nationwide. Affected healthcare facilities should contact the manufacturer, UFSK - International OSYS Gmbh, regarding appropriate remedial actions.
The recalled product
- Product
- UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
- Manufacturer
- UFSK - International OSYS Gmbh
- Affected units
- 239
Distribution
Distributed nationwide across the United States.
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