—#131705

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052412
Affected lot / code info: Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2014-09-04
Posted by FDA: 2014-12-16
Terminated: 2015-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.