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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94305

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

Open FDA event record

Event summary

Timeline bucket
March 18, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems, SCS

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

7 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 7

GE Healthcare Innova IGS 5, computed tomography x-ray system

Z-1777-2024
Recall number
Z-1777-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00840682124621, Serial Numbers: M2-23-042, M2-23-046, M2-23-048, M2-23-051, M2-24-001, M3-23-097, M3-23-098, M3-23-106, M3-23-108, M3-23-109, M3-23-111, M3-23-112, M3-23-114, M3-23-116, M3-23-123, M4-23-046, M4-23-053, M4-23-054, M4-23-055, M4-23-056, M4-24-001

Distribution pattern

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

device · product 2 of 7

GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

Z-1778-2024
Recall number
Z-1778-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00840682124614, Serial Numbers: B3-23-015, B3-23-016, B3-24-002;

Distribution pattern

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

device · product 3 of 7

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

Z-1779-2024
Recall number
Z-1779-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00840682141581, Serial Numbers: M4-23-049

Distribution pattern

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

device · product 4 of 7

GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems

Z-1780-2024
Recall number
Z-1780-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00195278215543, Serial Numbers: D4-23-035, D4-23-036, D4-23-038, D4-23-042, D4-24-001, D4-24-003

Distribution pattern

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

device · product 5 of 7

GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems

Z-1781-2024
Recall number
Z-1781-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00195278215550, Serial Numbers: D3-23-026, D4-24-002

Distribution pattern

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

device · product 6 of 7

GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

Z-1782-2024
Recall number
Z-1782-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00195278719263, Serial Numbers: M3-23-117

Distribution pattern

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

device · product 7 of 7

GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

Z-1783-2024
Recall number
Z-1783-2024
Initiated
March 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, SCS
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00195278719263, Serial Numbers: M3-23-117

Distribution pattern

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