PlainRecalls
FDA Devices Moderate Class II Terminated

MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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

Reported: March 15, 2017 Initiated: January 25, 2017 #Z-1436-2017

Product Description

MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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

Reason for Recall

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.

Details

Units Affected
35 systems
Distribution
Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, 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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 35 systems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1436-2017.