Recall Z-0107-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0107-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-08-18, terminated 2017-05-08. It names one FDA 510(k) clearance: K133589. Product: SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.. Reason: Software and firmware bugs.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-08-18
Terminated: 2017-05-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133589 — SOMATOM FORCESiemens Medical Solutions USA, Inc.·cleared 2014-04-17

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

SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.

Reason for recall

Software and firmware bugs

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