Z-0986-2022 Class II Ongoing
FDA device recall Z-0986-2022 was initiated by Siemens Medical Solutions USA, Inc on Feb 25, 2022 and is designated Class II. Reason for recall: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related… The recall status is ongoing. Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Reason for Recall
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Distribution Pattern
US Nationwide distribution.
Code Information
S/N: Serial 170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361 170351 170383 170023 170304 170328 170334 170336 170025 170346 170051 170358 170357 170333 170365 170332 170312 170027 170303 170378 170322 170053 170364 UDI: 04056869149325
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0986-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026