GE Healthcare, LLC: Medical Device Recall in 2014 - (Recall #: Z-0453-2015)

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:

Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.

Product Classification:

Class II

Date Initiated: September 4, 2014

Date Posted: December 24, 2014

Recall Number: Z-0453-2015

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: 6 (1 US, 5 OUS)

Code Information:

Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014

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