Siemens Medical Solutions USA, Inc Recall 89228
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
Siemens Medical Solutions USA, Inc Recall 89228 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0441-2022 |
| Event ID | 89228 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD. |
| Quantity | 13 units |
| Recall Reason | 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 |
| Device Classification | 20220105 |
| Device Code Info | Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911 |
| Center Classification Date | 20211229 |
| Recall Initiation Date | 20211209 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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