MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Recall
- Recall Number
- Z-1437-2017
- Event Number
- 76459
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 25, 2017
- Terminated
- October 6, 2017
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
Nationwide Distribution
35 systems