ARTIS icono recall
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Why was ARTIS icono recalled?
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
- Product
- ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 38 worldwide, 11 US
- Distribution
- US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)