Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling six Innova 4100IQ fluoroscopic imaging systems used to generate images of human anatomy for vascular angiography and diagnostic and interventional procedures. The devices may experience a loss of real-time interventional imaging and/or gantry motion due to electromagnetic sensitivity of the grid detection mechanism. The affected systems are distributed worldwide, including in California, Colorado, Florida, Missouri, and Pennsylvania in the United States, as well as Belgium, China, Colombia, France, Greece, Mexico, and Russia.
The recall involves six devices identified by specific serial numbers and lot codes. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA. Quantity: 6 (1 US, 5 OUS) Lot/code info: Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.