PlainRecalls
FDA Devices Moderate Class II Terminated

ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: 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: February 22, 2017 Initiated: January 25, 2017 #Z-1213-2017

Product Description

ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: 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 Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Details

Units Affected
194 systems
Distribution
United States distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: 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: 194 systems.
Why was this product recalled?
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1213-2017.