Recall Z-2212-2023 ยท HME Chair, Ophthalmic, Ac-Powered
UFSK - International OSYS Gmbh
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
| Date | Jul 20, 2023 (initiated May 31, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | UFSK email issued to distributors on May 3, 2023 action to take: 1a) distributor has to check their stock and quarantine affected chairs 1b) distributor has to identify customers who received treatment chairs with affected serial numbers 1c) distributor has to confirm via reply form to UFSK, that he has received and understood the action and will forward the safety notice to his customers. Distributors issued Urgent Medical Device Correction via email to Customers on May 31, 2023. Letter states reason for recall, health risk and action to take: Restricted use instructions as follows: The se |
| Quantity | 239 chairs US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.