UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeut
Summary
The FDA issued a Class II for UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the by UFSK - International OSYS Gmbh. 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.
Details
Source
Device Recall
External ID
Z-2212-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Art.no. / REF no.: 15000004 Serial number range: 2000- 2999 Art.no. / REF no.: 15000006 Serial number range: 3000-4506
Quantity Affected: 239 chairs US
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-31
Company
Ratisbon, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (UFSK - International OSYS Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does UFSK - International OSYS Gmbh have FDA actions?
This is the only FDA action we have on record for UFSK - International OSYS Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2212-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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