Z-1246-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- April 11, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Reason for Recall
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053