CLASS II ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
GE Healthcare Innova IGS 6, Interventional fluoroscopic recalled
GE Medical Systems SCS is recalling GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems, distributed nationwide in the US. The recall was initiated on 18 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1778-2024
- FDA event ID
- 94305
- Recalling firm
- GE Medical Systems SCS, Buc, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2024
- FDA classified
- 6 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 18 Mar 2024 | Recall initiated by company | |
| 6 May 2024 | Classified by FDA | +49 days |
| 15 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Where it was distributed
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
Nationwide CaliforniaFloridaGeorgiaIndianaMassachusettsNorth CarolinaOklahomaSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00840682124614, Serial Numbers: B3-23-015, B3-23-016, B3-24-002;
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 94305This product is part of a recall event; the main page for the event is GE Healthcare Allia IGS recalled by GE Medical Systems, SCS.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GE Healthcare Allia IGS recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide | |
| CLASS II | GE Healthcare Interact Discovery RT recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide | |
| CLASS II | GE Healthcare Allia IGS 5 Pulse recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide | |
| CLASS II | GE Healthcare Innova IGS 5, computed tomography x-ray system recalled | GE Medical Systems SCS | Other | Nationwide | |
| CLASS II | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems recalled | GE Medical Systems SCS | Other | Nationwide | |
| CLASS II | GE Healthcare Allia IGS 5 Pulse recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide |
More recalls from GE Medical Systems SCS
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GE Healthcare AW Server 3.2 ext.6.5 recalled by GE Medical Systems SCS | GE Medical Systems SCS | Other | Nationwide |
| Device | CLASS II | GE Healthcare Allia IGS 5 Pulse recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide |
| Device | CLASS II | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems recalled | GE Medical Systems SCS | Other | Nationwide |
| Device | CLASS II | GE Healthcare Innova IGS 5, computed tomography x-ray system recalled | GE Medical Systems SCS | Other | Nationwide |
| Device | CLASS II | GE Healthcare Allia IGS 5 Pulse recalled by GE Medical Systems, SCS | GE Medical Systems SCS | Other | Nationwide |
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