Siemens Medical Solutions USA, Inc Recall 89870
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
Siemens Medical Solutions USA, Inc Recall 89870 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0986-2022 |
| Event ID | 89870 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 35 units |
| Recall Reason | 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 movement s 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 |
| Device Classification | 20220427 |
| Device Code Info | 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 |
| Center Classification Date | 20220421 |
| Recall Initiation Date | 20220225 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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