—#197211

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 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: K142434
Affected lot / code info: UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

Why it was 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

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued Urgent Medical Device Correction Letter CSAN TH001/22/S to all affected customers on 11/09/2022. Letter states reason for recall, health risk and action to take: Siemens is developing the new syngo RT Therapist (RTT) software version RTT 4.3.1 MR4. With the new software version, the User will be able to load only one site at a time and avoid confusion of multiple displayed sites. If the User tries to download multiple sites from ARIA to syngo RT Therapist (RTT), the RTT will reject the complete patient load. If this occurs, User should immediately change their workflow by preparing one scheduler per planned site in ARIA. Availability of the new syngo RT Therapist (RTT) software version RTT 4.3.1 MR4 is currently unknown. Confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice by signing this document. Request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the ecommendations therein. Please ensure that this safety advisory is retained in your system Instructions for Use. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

Timeline

Recall initiated: 2022-11-09
Posted by FDA: 2022-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.