Recall Z-0183-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0183-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-23

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-09-23, terminated 2017-05-08. It names one FDA 510(k) clearance: K073290. Product: Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system 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: A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Terminated: 2017-05-08
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 zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system 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

A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.

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