Z-2212-2023Class II

UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic...

Name: Z-2212-2023 UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic...
Creator: UFSK - International OSYS Gmbh
Published: 2023-05-31
License: https://open.fda.gov/license/

UFSK - International OSYS GmbH / initiated 2023-05-31 / Open, Classified / root cause: design

FDA source

UFSK - International OSYS Gmbh began a recall of UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to... on 2023-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2212-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2023-07-20
Recalling firm: UFSK - International OSYS GmbH
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
Product code: HME Chair, Ophthalmic, Ac-Powered
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
Root cause tag: design
FDA root cause: Device Design
Action: UFSK email issued to distributors on May 3, 2023 action to take: 1a) distributor has to check their stock and quarantine affected chairs 1b) distributor has to identify customers who received treatment chairs with affected serial numbers 1c) distributor has to confirm via reply form to UFSK, that he has received and understood the action and will forward the safety notice to his customers. Distributors issued Urgent Medical Device Correction via email to Customers on May 31, 2023. Letter states reason for recall, health risk and action to take: Restricted use instructions as follows: The seat part drive is to be retracted so far with the patient in position that the seat part is in a horizontal position. Then the seat part may no longer be adjusted with the positioned patient. Attach the safety notice to the instructions for use of the respective treatment chair. Label the treatment chair appropriately using the information in the attachment to ensure safe use by changing users. If the seat drive is replaced, the backward inclination of the seat section can be used again. Follow-up measures: 7a) We urgently recommend to replace the seat part drive at the latest when the next safety inspection is carried out (interval 12 months). A replacement drive can be installed easily and without great effort. The successor model of the drive has a technically advanced self-locking mechanism for the motor and a mechanical end stop. The risk of the seat drive overrunning its end position due to wear when the seat section is tilted is then absolutely minimized. 7b) Update 500 XLE user & service manual with enclosed supplement. New contents: service plan for safety-relevant component, amended spare part list and installation instructions for the spare part drive. see document attached: Add_Manual_97000017_500XLE_SN2000-4506_40002535_230530_EN.pdf. Please contact UFSK-OSYS authorized US-Importer and distributor: Nautilus Surgical Inc., 2520 Horse Pasture Road Suite 103, Virgini
Quantity in commerce: 239 chairs US
Distribution: Nationwide
Product codes and lots: Art.no. / REF no.: 15000004 Serial number range: 2000- 2999 Art.no. / REF no.: 15000006 Serial number range: 3000-4506

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code HME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)