Recall Z-1278-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1278-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-19

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-02-19, terminated 2017-03-20. It names one FDA 510(k) clearance: K132094. Product: Cios Alpha, mobile X-ray system. Reason: Software issues on Cios Alpha mobile C-Arm system.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Terminated: 2017-03-20
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K132094 — CIOS ALPHASiemens Medi Cal Solutions, Inc.·cleared 2014-03-11

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

Cios Alpha, mobile X-ray system

Reason for recall

Software issues on Cios Alpha mobile C-Arm system

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