FDA Enforcement
Class II
Terminated
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
Recall: Z-0441-2022
·
Reported January 5, 2022
Enforcement
- Recall Number
- Z-0441-2022
- Event ID
- 89228
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 5, 2022
- Initiation Date
- December 9, 2021
- Classification Date
- December 29, 2021
- Termination Date
- May 4, 2023
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
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
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
Code Info
Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911
Distribution
US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Quantity
13 units