FDA-Device2023-07-26Class II
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
UFSK - International OSYS Gmbh
Hazard
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
Sold states
Nationwide
Affected count
239 chairs US
Manufactured in
Kirchhoffstr. 1, N/A, Ratisbon, N/A, Germany
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2023Don't want to check this manually?
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