Recall Z-2624-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2624-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-07-13, terminated 2017-01-24. It names one FDA 510(k) clearance: K143409. Product: SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system. Reason: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Terminated: 2017-01-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K143409 — SOMATOM Definition AS Open (VA48)Siemens Medical Solutions USA, Inc.·cleared 2015-03-26

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

SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system

Reason for recall

Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

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