Recall Z-1215-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1215-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-01-25, terminated 2018-10-01. It names one FDA 510(k) clearance: K993425. Product: PRIMUS 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: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Terminated: 2018-10-01
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K993425 — PRIMUSSiemens Medical Solutions USA, Inc.·cleared 1999-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PRIMUS 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.