ARTISTE with syngo RT Therapist version 4.3 Product recall: Impurity Out of Spec
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to…
Why was ARTISTE with syngo RT Therapist version 4.3 Product recalled?
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
All units of the version 4.3, Part No. 08162815
- Product
- ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 8 units
- Distribution
- Worldwide distribution
- Recall date
- June 26, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)