Recall Z-0854-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0854-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-17

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-09-17, terminated 2015-08-06. It names one FDA 510(k) clearance: K073290. Product: Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.. Reason: The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-17
Terminated: 2015-08-06
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/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reason for recall

The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.

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