—#130163

Product

Innova IGS 540 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.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K122457
Affected lot / code info: Mfg Lot or Serial # System ID 00000642076BU4 303695IR1 00000642193BU7 0004040462 00000646910BU0 314768SM10 00000647792BU1 904UFHNSP 00000646492BU9 XV386041GE8 00000646048BU9 S4160099 00000644611BU6 H2009VAS44 00000646493BU7 H0008VAS06 00000645027BU4 XV106184CX5 00000646491BU1 4184240

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 #130163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.