UFSK - International OSYS Gmbh recalls UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeu…

Recall date

May 31, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2212-2023

FDA classification

Class II

Brand / firm

UFSK - International OSYS Gmbh

Sold / distributed

Nationwide

Why it 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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