Z-0441-2022 Class II Terminated
FDA device recall Z-0441-2022 was initiated by Siemens Medical Solutions USA, Inc on December 9, 2021 and is designated Class II. 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 se… The recall status is terminated (terminated May 4, 2023). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- December 9, 2021
- Termination Date
- May 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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
Distribution Pattern
US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Code Information
Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911