Z-2386-2018Class II

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

Name: Z-2386-2018 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Creator: GE Medical Systems, SCS
Published: 2018-03-29
License: https://open.fda.gov/license/

GE Medical Systems SCS / initiated 2018-03-29 / Terminated / root cause: manufacturing process

FDA source

GE Medical Systems, SCS began a recall of Discovery IGS 730 Interventional Fluoroscopic X-ray Systems on 2018-03-29. FDA classified it as Class II and gives the reason as "The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2386-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Posted: 2018-10-05
Terminated: 2021-06-15
Recalling firm: GE Medical Systems SCS
Product: Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare notified customers on approximately 03/29/2018, via an URGENT MEDICAL DEVICE CORRECTION letter. Safety instructions included that before each use, to ensure the IGS system is fully functional as indicated in the GE product labeling and follow each facility's established procedures before and during each use to manage the patient if a repeated X-ray abort error occurs during the procedure or in the case a complete loss of fluoroscopic viewing capability may occur. If the problem persists, customers are instructed to contact their local GE Healthcare Service Representative. Additionally, customers are instructed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or the local Service Representative.
Quantity in commerce: 102 devices total
Distribution: US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.
Product codes and lots: Model Number 5730890, Serial Numbers (System ID): 00000D3-17-030 (904BHHCHY), 00000D3-17-032 (083172440628), 661327IGS730 (00000D3-18-001), GON4598369 (00000D3-18-004), 082416140028 (00000D3-17-025), M4234253 (00000D3-17-028), YV3601 (00000D3-18-005), 6073XR0058 (00000D3-17-031).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2386-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2386-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06
Z-2387-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06
Z-2388-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06

Product code OWB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)