Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98880

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 20, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Allia IGS 3 Pulse angiographic X-ray system

Z-2314-2026
Recall number
Z-2314-2026
Initiated
April 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 2 of 5

Allia IGS 5 Pulse angiographic X-ray system

Z-2315-2026
Recall number
Z-2315-2026
Initiated
April 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
121 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00195278719263; Serial Numbers: M2-23-039, M2-23-056, M2-24-004, M2-24-019, M2-24-020, M2-24-025, M2-24-030, M2-24-031, M2-24-032, M2-24-033, M2-24-034, M2-24-037, M2-24-038, M2-24-039, M2-24-040, M2-24-046, M2-24-057, M2-24-062, M2-24-064, M2-24-066, M2-24-069, M2-24-071, M2-24-077, M2-24-078, M2-24-080, M2-24-083, M2-25-003, M2-25-004, M2-25-005, M2-25-011, M2-25-013, M2-25-015, M2-25-017, M2-25-019, M2-25-023, M2-25-024, M2-25-025, M2-25-026, M2-25-028, M2-25-032, M2-25-036, M2-25-037, M2-25-039, M2-25-040, M2-25-041, M2-25-042, M2-25-043, M2-25-046, M2-25-048, M2-25-049, M2-25-056, M2-25-057, M2-25-058, M2-25-062, M2-25-065, M2-25-067, M2-25-072, M2-25-074, M2-25-077, M2-25-078, M2-25-080, M2-25-250, M2-25-300, M2-26-002, M2-26-004, M2-26-006, M2-26-007, M2-UP2502, M3-22-012, M3-23-117, M3-24-019, M3-24-021, M3-24-023, M3-24-034, M3-24-052, M3-24-061, M3-24-074, M3-24-079, M3-24-086, M3-24-090, M3-24-094, M3-24-095, M3-24-097, M3-24-099, M3-24-101, M3-24-104, M3-24-111, M3-24-120, M3-24-128, M3-24-136, M3-24-137, M3-24-141, M3-24-143, M3-24-149, M3-24-151, M3-24-156, M3-24-159, M3-24-161, M3-24-163, M3-24-165, M3-24-168, M3-24-169, M3-24-172, M3-24-175, M3-25-003, M3-25-012, M3-25-017, M3-25-020, M3-25-027, M3-25-036, M3-25-061, M3-25-063, M3-25-069, M3-25-074, M3-25-076, M3-25-079, M3-25-080, M3-25-084, M3-25-085, M3-25-088, M3-25-089, M3-25-094, M3-25-104, M3-25-106, M3-25-107, M3-25-115, M3-25-118, M3-25-119, M3-25-120, M3-25-128, M3-25-130, M3-25-132, M3-25-145, M3-25-147, M3-25-148, M3-25-149, M3-25-150, M3-25-151, M3-26-002, M3-26-003, M3-26-005, M3-26-007, M3-26-021, M3-26-024, M3-26-027, M3-26-028, M3-26-033, M3-26-034, M3-UP2501, M3-UP2503

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 3 of 5

Allia IGS 7 Pulse angiographic X-ray system

Z-2316-2026
Recall number
Z-2316-2026
Initiated
April 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 4 of 5

Allia IGS Pulse angiographic X-ray system

Z-2317-2026
Recall number
Z-2317-2026
Initiated
April 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 5 of 5

Allia Moveo angiographic X-ray system

Z-2318-2026
Recall number
Z-2318-2026
Initiated
April 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

Distribution pattern

Worldwide - US Nationwide distribution.

Field note

Send feedback

We'll only use this to respond to your feedback.