Z-0451-2015Class II

Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and...

Name: Z-0451-2015 Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and...
Creator: GE Healthcare, LLC
Published: 2014-09-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-09-04 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular... on 2014-09-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0451-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Posted: 2014-12-16
Terminated: 2015-01-21
Recalling firm: GE Healthcare
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.
Product code: IZI System, X-Ray, Angiographic
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 10 (4 US, 6 OUS).
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0451-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0451-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12
Z-0452-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12
Z-0453-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12

Product code IZI

K122457Class IIGe Innova/innova Igs/discovery Igs/optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers SolutionsGE Healthcare / cleared 2013-01-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)