Artiste recall
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator…
Why was Artiste recalled?
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
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?
UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3
- Product
- ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 8 units US
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
- Recall date
- December 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)