Recall Z-2212-2023— UFSK - International OSYS Gmbh
Class II · Ongoing
Class II FDA medical device recall by UFSK - International OSYS Gmbh, initiated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position.
- Recalling firm
- UFSK - International OSYS Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-31
- Firm location
- Ratisbon, N/A, Germany
Product description
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
Reason for recall
Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position
Data sourced from openFDA. This site is unofficial and independent of the FDA.