HIGH

GE HealthCare Recalls 28 Elscint SPX6 Gamma Cameras Worldwide in 2025

GE HealthCare is recalling 28 Elscint SPX6 dual-head gamma cameras worldwide. The recall cites detectors could be stressed during transport or relocation without adequate detector support, risking a detector fall and life-threatening injury. Hospitals should stop using the devices and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
GE HealthCare
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 Elscint SPX6 is a dual-head gamma camera used in nuclear medicine for cardiac imaging. It is part of advanced imaging used in diagnostic radiology.

Why This Is Dangerous

If transported without proper detector support, mounting stress can compromise detector integrity, potentially causing a detector fall with life-threatening implications.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals and clinics may need to halt imaging using affected units and coordinate with the manufacturer for service or replacement to prevent patient harm.

Practical Guidance

How to identify if yours is affected

  1. Verify if your facility owns an Elscint SPX6 gamma camera.
  2. Confirm serial numbers: all serial numbers in distribution are affected.
  3. Review the recall notice and contact the manufacturer for instructions.

Where to find product info

Recall notice and contact details are available on the FDA enforcement page linked in the data.

What timeline to expect

No timeline is provided in the data; follow the manufacturer's instructions for service or recall actions.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • Escalate to hospital risk management or regulatory affairs if the manufacturer is slow to respond.

How to prevent similar issues

  • Ensure transport and relocation procedures follow detector mounting guidance.
  • Maintain service records and verify End of Guaranteed Service status before moving equipment.
  • Verify recall participation and obtain written instructions before resuming use after service.

Documentation advice

Keep the recall notice, service correspondence, and any technician reports as part of compliance and safety records

Product Details

Model: Elscint SPX6. All serial numbers in distribution. Sold worldwide. No individual price data available.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 28 units affected worldwide
  • Elscint SPX6 dual-head gamma camera
  • Detectors may suffer mounting stress leading to potential detector fall
  • End of Guaranteed Service context

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
SUFFOCATIONELECTRICALCRUSHINGFALL

Product Classification

Product Details

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

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