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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 HealthCare Gamma Cameras Recalled for Potential Detector Fall Hazard

Agency Publication Date: October 23, 2025
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Summary

GE HealthCare is recalling 2,325 units of various dual-head nuclear medicine gamma cameras designed for cardiac imaging. The company discovered that older systems, which are past their guaranteed service period, may have been moved or transported without proper support for their heavy detectors. This can damage the mounting mechanisms, potentially causing a detector to fall during use, which could result in life-threatening bodily injury to patients or medical staff. Affected brands include various models under the Elscint, Millenium, Maxicam, and Sopha Medical Vision names.

Risk

If the detector mounting mechanisms fail, the heavy medical imaging detector could fall onto a patient or staff member. This failure poses a significant risk of severe impact and life-threatening injury.

What You Should Do

  1. This recall involves several models of GE HealthCare dual-head nuclear medicine gamma cameras, including Elscint Cardial, 4XX, SPX4, SPX6, Varicam, and Helix; Maxicam; Millenium MG/MC, Myosight, MPR, and MPS; Optima NX; Sopha Medical Vision (SMV) DSXi, DST-XLi, DST-XL, and DSTi; and Starcam/Camstar systems.
  2. Hospitals and imaging centers should identify if their specific system is affected by checking the model and serial number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Elscint Cardial; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Cardial
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0290-2026; 11 units affected.

Product: Elscint Model 4XX; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Model 4XX
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0291-2026; 64 units affected.

Product: Elscint SPX4; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
SPX4
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0292-2026; 45 units affected.

Product: Elscint SPX6; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
SPX6
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0293-2026; 28 units affected.

Product: Elscint Varicam; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Varicam
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0294-2026; 15 units affected.

Product: Elscint Helix; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Helix
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0295-2026; 3 units affected.

Product: Maxicam; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Maxicam
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0296-2026; 37 units affected.

Product: Millenium MG/MC; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
MG/MC
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0297-2026; 1386 units affected.

Product: Millenium Myosight; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Myosight
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0298-2026; 82 units affected.

Product: Millenium MPR; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
MPR
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0299-2026; 292 units affected.

Product: Millenium MPS; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
MPS
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0300-2026; 54 units affected.

Product: Optima NX; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Optima NX
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0301-2026; 1 unit affected.

Product: Sopha Medical Vision (SMV) DSXi/DST-XLi/DST-XL/DSTi; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
DSXi
DST-XLi
DST-XL
DSTi
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0302-2026; 205 units affected.

Product: Starcam/Camstar; dual-head nuclear medicine gamma camera
Variants: Cardiac imaging
Model / REF:
Starcam
Camstar
Serial Numbers:
all serial numbers in distribution

System is past the End of Guaranteed Service; Recall # Z-0303-2026; 102 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97647
Status: Active
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sold By: GE Medical Systems Israel, Functional Imaging; Authorized Medical Device Distributors; Hospitals and Medical Imaging Centers
Manufactured In: Israel
Units Affected: 14 products (11 units; 64 units; 45 units; 28 units; 15 units; 3 units; 37 units; 1386 units; 82 units; 292 units; 54 units; 1 unit; 205 units; 102 units)
Distributed To: Nationwide

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.