UFSK Treatment chair 500 XLE- Treatment chair for positioning and… — Class II medical device recall Z-2212-2023
Ongoing recall by UFSK - International OSYS Gmbh, reported 2023-07-26, distributed nationwide. Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after seve
| Recall number | Z-2212-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | UFSK - International OSYS Gmbh, Ratisbon, N/A, Germany |
| Recall initiated | 2023-05-31 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 239 chairs |
| Model numbers | 15000004, 15000006 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2212-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.