ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Reported: January 5, 2022 Initiated: December 9, 2021 #Z-0441-2022
Product Description
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Reason for Recall
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 13 units
- Distribution
- US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 13 units.
Why was this product recalled? ▼
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 5, 2022. Severity: Moderate. Recall number: Z-0441-2022.
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