Recall Z-1182-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1182-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-04

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-04-04, terminated 2013-08-12. It names 3 FDA 510(k) clearances: K103606, K060226, K993425. Product: Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.. Reason: Software update to fix multiple safety related issues..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Terminated: 2013-08-12
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K103606 — ARTISTE SOLUTION WITH SYS_VB50 UPDATESiemens Medical Solutions USA, Inc.·cleared 2011-04-15
K060226 — ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc.·cleared 2006-03-15
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

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

Software update to fix multiple safety related issues.

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