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
Product summary
- 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
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.