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.
Reported: December 21, 2022 Initiated: November 9, 2022 #Z-0472-2023
Product Description
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.
Reason for Recall
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 8 units US
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 8 units US.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0472-2023.
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