Recall record at a glance
| Official record | Z-2212-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | UFSK - International OSYS Gmbh |
| Report date | Jul 26, 2023 |
| Recall initiation date | May 31, 2023 |
| Quantity | 239 chairs US |
| Location | Ratisbon, N/A, Germany |
Official 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
Why the product was recalled
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
Distribution information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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