Recall Z-1433-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1433-2017
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 2017-10-06. It names one FDA 510(k) clearance: K790688. Product: MEVATRON M 6700 (MX) 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: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Terminated: 2017-10-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K790688 — MEVATRON 67Siemens Medical Laboratories, Inc.·cleared 1979-04-23

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

MEVATRON M 6700 (MX) 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.

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