Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0452-2015

September 04, 2014

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 69286
Status
Terminated
Classification
Class II
Quantity
1 - OUS
Official record key
device-enforcement:Z-0452-2015

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.