HIGH

GE Healthcare Recalls 82 Millenium Myosight Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare recalled 82 Millenium Myosight dual-head gamma cameras distributed worldwide. The devices could have been moved without adequate detector mounting support. This could cause a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the cameras immediately and follow manufacturer recall instructions.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
GE Healthcare, GE Medical Systems Israel, Functional Imaging
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Millenium Myosight gamma camera is a dual-head nuclear medicine imaging device used to perform cardiac imaging studies in hospitals. It requires precise detector mounting to ensure accurate imaging.

Why This Is Dangerous

If the detector mounting is stressed due to improper handling, the detector could detach or fall, posing a serious risk to patients and staff.

Industry Context

This recall is not described as part of a broader industry-wide pattern.

Real-World Impact

Hospitals may experience equipment downtime and require service interventions. The recall pertains to life-threatening injury risk during transport or relocation of the device.

Practical Guidance

How to identify if yours is affected

  1. Verify device is a Millenium Myosight dual-head gamma camera.
  2. Confirm serial numbers are in distribution (all serial numbers).
  3. Check whether the device has recently been relocated or transported without appropriate mounting procedures.

Where to find product info

Serial numbers should be on the device label near the detector mounting and in the facility's service records.

What timeline to expect

Manufacturer guidance will specify remediation steps and timelines. Typical hospital remediation can span weeks to months depending on service parts.

If the manufacturer is unresponsive

  • Escalate to hospital risk management and the national regulatory body if the manufacturer is slow to respond.
  • Document all requests and responses with the manufacturer.

How to prevent similar issues

  • Implement strict handling procedures for transporting nuclear imaging equipment.
  • Verify detector mounting integrity during any relocation.
  • Maintain up-to-date service records and end-of-life service status to identify risks earlier.

Documentation advice

Photograph device labels, keep the recall notice and correspondence, log serial numbers and relocation histories.

Product Details

Product: Millenium Myosight dual-head gamma camera. Serial numbers: All serial numbers in distribution. Sold: Worldwide. Recall date: 2025-09-12. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 82 units recalled
  • Worldwide distribution
  • Detectors could detach if mounting is stressed
  • Recall date 2025-09-12
  • Active recall with high hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
FALLCRUSHINGOTHER

Product Details

Model Numbers
Millenium Myosight dual-head gamma camera
Report Date
October 29, 2025
Recall Status
ACTIVE

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