Artis icono floor in combination with a Siemens recall: Software Issue
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging…
Why was Artis icono floor in combination with a Siemens recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 35 units
- Distribution
- US Nationwide distribution.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)