FDA recall Z-2212-2023

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

Reason for recall

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

Nationwide

Key facts

Status

Ongoing

Initiation date

2023-05-31

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ratisbon, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2023