Recall Z-0438-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0438-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-23

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-10-23, terminated 2014-01-22. It names one FDA 510(k) clearance: K072485. Product: SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA. Reason: A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Terminated: 2014-01-22
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072485 — ARTISTE MV SASiemens Medical Solutions USA, Inc.·cleared 2007-12-27

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

SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA

Reason for recall

A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

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