Z-1779-2024Class II

GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

Name: Z-1779-2024 GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Creator: GE Medical Systems, SCS
Published: 2024-03-18
License: https://open.fda.gov/license/

GE Medical Systems SCS / initiated 2024-03-18 / Open, Classified / root cause: manufacturing process

FDA source

GE Medical Systems, SCS began a recall of GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems on 2024-03-18. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1779-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-18
Posted: 2024-05-06
Recalling firm: GE Medical Systems SCS
Product: GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare issued an UGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/18/2024 via letter. The notice explained the issue, hazard, and requested the following actions be taken: Every day prior to first use of the device, perform a functional check of the gantry movements and images of your device to look for the following behaviors: 1. Abnormal noise during gantry movement. 2. Image misalignment. If any of the above is observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Post this letter in a visible location beside the product. GE HealthCare will schedule a service appointment to correct this potential issue in a timely manner. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 1 unit
Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
Product codes and lots: UDI/DI 00840682141581, Serial Numbers: M4-23-049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1779-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1777-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1778-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1779-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1780-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1781-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1782-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06
Z-1783-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06

Product code OWB

K232344Class IIAllia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS / cleared 2023-10-11

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)