Recall Z-1645-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1645-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-04-01, terminated 2014-12-11. It names 2 FDA 510(k) clearances: K072485, K031764. Product: 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.. Reason: Table may lose calibration during patient treatment, which may cause the possibility of mistreatment..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Terminated: 2014-12-11
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K072485 — ARTISTE MV SASiemens Medical Solutions USA, Inc.·cleared 2007-12-27
K031764 — ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc.·cleared 2003-09-05

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

550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.

Reason for recall

Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

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