Z-1246-2022 Class II Ongoing
FDA device recall Z-1246-2022 was initiated by Siemens Medical Solutions USA, Inc on Apr 11, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- Apr 11, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1246-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026