Z-0452-2015Class II

Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and...

Name: Z-0452-2015 Discovery IGS 740 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 Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for... 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-0452-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Posted: 2014-12-16
Terminated: 2015-01-21
Recalling firm: GE Healthcare
Product: Discovery IGS 740 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: OWB Interventional Fluoroscopic X-Ray System
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: 1 - 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 00000646778BU1 190020RX26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0452-2015
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 OWB

K133278Class IIDiscovery Igs 740GE Medical Systems SCS / cleared 2014-04-24

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)