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Recall Observatory FDA recall evidence

Device 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

Z-2212-2023

May 31, 2023

Class II

Product summary

Firm
UFSK - International OSYS Gmbh
Event
Event 92534
Status
Ongoing
Classification
Class II
Quantity
239 chairs US
Official record key
device-enforcement:Z-2212-2023

Official wording

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

Code information: Art.no. / REF no.: 15000004 Serial number range: 2000- 2999 Art.no. / REF no.: 15000006 Serial number range: 3000-4506

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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