GE Healthcare, LLC: Medical Device Recall in 2014 - (Recall #: Z-0452-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Product Classification:

Class II

Date Initiated: September 4, 2014
Date Posted: December 24, 2014
Recall Number: Z-0452-2015
Event ID: 69286
Reason for Recall:

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Status: Terminated
Product Quantity: 1 - OUS
Code Information:

Mfg Lot or Serial # System ID 00000646778BU1 190020RX26

Distribution Pattern:

Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.

Voluntary or Mandated:

Voluntary: Firm initiated