Recall Z-0118-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0118-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-17

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-08-17, terminated 2016-12-05. It names one FDA 510(k) clearance: K132094. Product: CIOS ALPHA; image intensified fluoroscopic x-ray system. Reason: patient procedure interruption due to a potential system failure.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-08-17
Terminated: 2016-12-05
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; image intensified fluoroscopic x-ray system

Reason for recall

patient procedure interruption due to a potential system failure

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