Recalls / —
—#118888
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 deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K121295
- Affected lot / code info
- All units of the version 4.3, Part No. 08162815
Why it was 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.
Root cause (FDA determination)
Device Design
Action the firm took
Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 757 Arnold Dr, Ste A, Martinez, California 94553-3615
Distribution
- Distribution pattern
- Worldwide distribution
Timeline
- Recall initiated
- 2013-05-29
- Posted by FDA
- 2013-06-21
- Terminated
- 2013-11-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118888. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.