Recall Z-1824-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1824-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-28

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-03-28, terminated 2017-08-07. It names one FDA 510(k) clearance: K073290. Product: Artis zee, Angiographic x-ray system. Reason: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Terminated: 2017-08-07
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K073290 — ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc.·cleared 2008-02-11

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

Artis zee, Angiographic x-ray system

Reason for recall

Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.

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