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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Medical Systems, SCS: Imaging Systems Recalled for Potential Falling Gantry Components

Agency Publication Date: May 6, 2024
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Summary

GE HealthCare has recalled 35 imaging and interventional X-ray systems, including various Innova, Discovery, Interact, and Allia IGS models. The recall was initiated because certain bolts in the gantry assembly may not have had necessary adhesive material applied during manufacturing. This defect can cause the heavy X-ray tube or the detector/elevator assembly to fall unexpectedly. These systems were distributed nationwide and globally between 2023 and early 2024. Consumers should contact GE HealthCare immediately for further instructions and to schedule a service inspection.

Risk

If the bolts securing the X-ray components loosen due to the missing adhesive, the frontal gantry assembly parts could fall on a patient or healthcare provider. This poses a significant risk of serious physical injury or death during a medical procedure.

What You Should Do

  1. Identify if your facility is using any of the affected GE HealthCare systems: Innova IGS 5, Innova IGS 6, Interact Discovery RT, Allia IGS 7, Allia IGS 7 OR, or Allia IGS 5 Pulse.
  2. Check the serial number on your system against the affected list, which includes specific numbers like M2-23-042, M3-23-097, B3-23-015, M4-23-049, D4-23-035, and D3-23-026 among others.
  3. Contact your GE HealthCare representative or the manufacturer directly to confirm if your specific unit requires an inspection or repair.
  4. Follow all instructions provided by your healthcare provider or the manufacturer regarding the continued use of the equipment until it has been inspected.
  5. For further information or to report issues, contact GE HealthCare at the number provided in your firm notification letter or contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer inspection and corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE Healthcare Innova IGS 5, computed tomography x-ray system
Model / REF:
Z-1777-2024
UPC Codes:
00840682124621
Lot Numbers:
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
Product: GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Model / REF:
Z-1778-2024
UPC Codes:
00840682124614
Lot Numbers:
Serial Numbers: B3-23-015
B3-23-016
B3-24-002
Product: GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Model / REF:
Z-1779-2024
UPC Codes:
00840682141581
Lot Numbers:
Serial Number: M4-23-049
Product: GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
Model / REF:
Z-1780-2024
UPC Codes:
00195278215543
Lot Numbers:
Serial Numbers: D4-23-035
D4-23-036
D4-23-038
D4-23-042
D4-24-001
D4-24-003
Product: GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Model / REF:
Z-1781-2024
UPC Codes:
00195278215550
Lot Numbers:
Serial Numbers: D3-23-026
D4-24-002
Product: GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Model / REF:
Z-1782-2024
Z-1783-2024
UPC Codes:
00195278719263
Lot Numbers:
Serial Number: M3-23-117

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94305
Status: Active
Manufacturer: GE Medical Systems, SCS
Sold By: GE Medical Systems; Direct Sales
Manufactured In: France
Units Affected: 7 products (21 units; 3 units; 1 unit; 6 units; 2 units; 1 unit; 1 unit)
Distributed To: California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.