GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for

FDA device recall Z-0021-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
Action taken: Consignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).
Root cause: Process control
Status: Terminated
Product code: OWB
Quantity affected: 2184 (1063 US. 1121 OUS)
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA,
Date initiated: 2013-08-16
Date posted: 2013-10-17
Date terminated: 2014-05-30
Location: Waukesha, WI

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