CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Allia IGS 7 Pulse angiographic X-ray system recalled
GE Medical Systems is recalling Allia IGS 7 Pulse angiographic X-ray system, distributed nationwide in the US. The recall was initiated on 20 Apr 2026 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-2316-2026
- FDA event ID
- 98880
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Apr 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 20 Apr 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +46 days |
| 17 Jun 2026 | Published in enforcement report | +12 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 a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Product as listed by the FDA
Allia IGS 7 Pulse angiographic X-ray system
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Which lots are affected?
UDI-DI: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007
Where was it sold?
Worldwide - US Nationwide distribution.
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
4 other products · FDA event 98880This product is part of a recall event; the main page for the event is Allia IGS 3 Pulse angiographic X-ray system recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Allia IGS 3 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Allia IGS Pulse angiographic X-ray system recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide | |
| CLASS II | Allia Moveo angiographic X-ray system recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide | |
| CLASS II | Allia IGS 5 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 5 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
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| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |