Z-0523-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 worldwide, 11 US
Product Description
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Reason for Recall
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.
Distribution Pattern
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
Code Information
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100