Recall Z-1077-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1077-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-12-20, terminated 2013-07-19. It names one FDA 510(k) clearance: K123230. Product: ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.. Reason: A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Terminated: 2013-07-19
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2012-12-12

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

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.

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