GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoro

FDA device recall Z-0133-2012 · posted 2011-10-28 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQB

Quantity affected

15

Distribution

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

Date initiated

2011-08-24

Date posted

2011-10-28

Date terminated

2012-05-29

Location

Waukesha, WI

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