What is being recalled?

28 Elscint SPX6 dual-head gamma cameras used for cardiac imaging are being recalled due to a risk of detector mounting stress during transport or relocation without adequate support.

Excessive stress on detector mounting mechanisms could cause a detector fall and life-threatening injury.

All serial numbers in distribution of the Elscint SPX6 gamma camera are affected.

What should facilities do now?

Stop using the devices and follow the recall instructions from GE HealthCare. Contact GE Medical Systems Israel Functional Imaging for instructions.

Are there any injuries reported?

No injuries or incidents have been reported to date.

Where can I find the recall notice?

The recall notice is available on the FDA enforcement page linked in the data.

Will the device be repaired or replaced?

Remedy details specify stopping use and following manufacturer instructions; repair or service arrangements will be provided by GE HealthCare.

How long will the process take?

The data does not specify a timeline; follow the manufacturer’s instructions for next steps.

Do I need to alert authorities or regulators?

Follow the recall instructions from GE HealthCare and notify your local regulatory authority as advised by your institution.

What should purchasing facilities do to prevent this in the future?

Ensure proper transport and servicing protocols for high-risk imaging equipment and verify compliance with post-sale service requirements.

HIGHSeptember 12, 2025

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

Verify if your facility owns an Elscint SPX6 gamma camera.
Confirm serial numbers: all serial numbers in distribution are affected.
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

View Original Recall on FDA - Medical Devices

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Safety Guide

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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

GE HealthCare Israel recalled 37 Maxicam dual-head gamma cameras distributed worldwide to hospitals. The recall cites potential detector mounting stress if the devices are moved without adequate support. This could result in a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the device and follow recall instructions from GE HealthCare.

Sep 12, 2025

GE HealthCare