Class 2 Device Recall UFSKInternational OSYS GmbH

• Date Initiated by Firm: May 31, 2023
• Date Posted: July 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2212-2023
• Recall Event ID: 92534
• Product Classification: Chair, ophthalmic, ac-powered - Product Code HME
• 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
• Code Information: Art.no. / REF no.: 15000004 Serial number range: 2000- 2999 Art.no. / REF no.: 15000006 Serial number range: 3000-4506
• Recalling Firm/ Manufacturer: UFSK - International OSYS Gmbh; Kirchhoffstr. 1; Ratisbon Germany
• Manufacturer 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
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.