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GE HealthCare Recalls 102 Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare recalled 102 dual-head gamma cameras used for cardiac imaging worldwide after finding that some systems past the End of Guaranteed Service could be moved without adequate detector support. This could place excessive stress on detector mounting mechanisms and may cause a detector to fall, posing life-threatening risk. Hospitals and healthcare providers should stop using the devices IM

Official notice
GE HealthCareHealth & Personal CareMedical DevicesAll serial numbers in distribution

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 12, 2025
Status
ACTIVE
Severity
9/10

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
GE HealthCare
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
GE HealthCare
Product type
Nuclear Medicine Gamma Camera
Model numbers
All serial numbers in distribution
Sold at
Unknown

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 12, 2025

  2. Reported by FDA DEVICE

    October 29, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The Starcam/Camstar dual-head gamma camera is used in nuclear medicine for cardiac imaging. Hospitals rely on these devices for diagnostic imaging procedures.

Why This Is Dangerous

The device could be moved without adequate detector support, causing stress on mounting hardware. This may lead to a detector fall and life-threatening injuries.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects hospital imaging workflows. Immediate device removal from service may cause temporary disruption in patient scheduling and imaging services.

Practical Guidance

How to identify if yours is affected

  1. Confirm the device is a GE HealthCare dual-head gamma camera used for cardiac imaging.
  2. Check if the serial number is among the recall notice: all serial numbers in distribution are included.
  3. Review the recall letter from GE HealthCare for specific instructions.

Where to find product info

Recall notice and instructions are available via the FDA enforcement page linked in the provided data.

What timeline to expect

Follow manufacturer instructions. Timelines for service or replacement will be provided by GE HealthCare.

If the manufacturer is unresponsive

  • Document all contact attempts with the manufacturer.
  • Escalate to hospital administration and regulatory authorities if the manufacturer is unresponsive.

How to prevent similar issues

  • Do not relocate or transport gamma cameras without proper detector mounting and support.
  • Verify and document detector mounting integrity during any service or relocation.

Documentation advice

Keep a copy of the recall letter, record serial numbers, capture photos of mounting hardware, and log all communications with the manufacturer.

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Product Details

Model numbers: All serial numbers in distribution. Where sold: Worldwide distribution to healthcare facilities. When sold: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 102 units recalled worldwide
  • All serial numbers in distribution are affected
  • Hazard: detector mounting stress could lead to detector fall
  • No injuries or incidents reported to date
  • Stop use immediately and follow manufacturer recall instructions
  • Contact GE HealthCare Israel, Functional Imaging or your provider for next steps

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
9/ 10
Affected Groups
GENERAL
Injury Types
CRUSHING

Product Details

Model Numbers
All serial numbers in distribution
Report Date
October 29, 2025
Recall Status
ACTIVE

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