—#103005

Product

GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042053, K052157, K052412, K061163, K092004
Affected lot / code info: 00000002010011 599032BU0 00000002011001 00000002011002 598347BU3 00000002010013 00000002010017 00000002010012 00000002010014 00000002010015 599038BU7 00000002010016 00000002010010 00000002011003 00000002010007

Why it was recalled

A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A GE Healthcare "Urgent Medical Device Correction" letter dated August 22, 2011 was sent out 8/24/11. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were told to operate the suspension without excessive force. If one of the end-stops breaks, then the system should not be used and their local GE Healthcare Service Representative should be contacted. GE will contact customers to replace all end-stops at no cost to the customer. Questions or concerns should be directed to 800-437-1171 in the US and 0120-055-919 in Japan. For other countries, customers can contact their local GE Healthcare Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution -- USA, including the states of TX & NC and the countries of TURKEY, POLAND, MEXICO, CHINA, CAMBODIA, BRAZIL, BOLIVIA, and SAUDI ARABIA.

Timeline

Recall initiated: 2011-08-24
Posted by FDA: 2011-10-28
Terminated: 2012-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.