Z-2253-2013Class II

GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are...

Name: Z-2253-2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are...
Creator: GE Healthcare, LLC
Published: 2013-06-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-06-19 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and... on 2013-06-19. FDA classified it as Class II and gives the reason as "GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2253-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Posted: 2013-09-18
Terminated: 2013-10-25
Recalling firm: GE Healthcare
Product: GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma
Root cause tag: software
FDA root cause: Software design
Action: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 19, 2013 to its Consignees/customers. The letter described the Safety Issue, Safely Instructions, Affected Product Detail, Product Correction and Contact Information. The consignees were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call : United States: 800 437 1171. For other countries, please contact your local GE Healthcare Service Representative.
Quantity in commerce: 4 (2 US, 2 OUS)
Distribution: Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.
Product codes and lots: Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2253-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18

Product code OWB

K113403Class IIGe Discovery Igs Angiographic,fluoroscopic X-Ray SystemGE Medical Systems SCS / cleared 2012-02-14

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)