Recall Z-1562-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1562-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-05-29, terminated 2013-11-26. It names one FDA 510(k) clearance: K121295. Product: ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.. Reason: The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Terminated: 2013-11-26
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K121295 — ARTISTETM SOLUTION WITH SYS VCIOSiemens Medical Solutions USA, Inc.·cleared 2012-06-27

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

ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.

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