Is this recall related to patient safety?

Yes. The recall identifies a risk of detector mounting failure that could lead to a detector fall and potential life-threatening injury. No injuries have been reported to date.

How many units are affected?

37 Maxicam dual-head gamma cameras are affected worldwide.

Who should stop using the device?

Hospitals and healthcare providers should stop using affected units and follow GE HealthCare’s recall instructions.

Where can I find the official recall notice?

The FDA enforcement listing for Z-0296-2026 provides official recall details.

What should facilities do next?

Refer to GE HealthCare’s recall instructions and coordinate with biomedical engineering for replacement or repair guidance.

Will there be a refund or replacement?

Remedy details are provided by the manufacturer; follow recall communications for refunds, replacements, or service options.

How do I identify if my device is affected?

Review serial numbers and model name; this recall covers all Maxicam dual-head gamma cameras with distribution in the recall.

Who issued the recall?

GE HealthCare Israel, Functional Imaging issued the recall notice.

What is the hazard level?

The recall is classified as HIGH risk with potential life-threatening injury.

What is the location of the recall?

Worldwide distribution to hospitals and clinics is affected.

HIGHSeptember 12, 2025

GE HealthCare Recalls 37 Maxicam Dual-Head Gamma Cameras for Cardiac Imaging (2025)

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.

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

Maxicam is a dual-head gamma camera used for cardiac imaging and other nuclear medicine applications.

Why This Is Dangerous

If transported or relocated without adequate detector support, stress can damage detector mounting and lead to a detector fall.

Industry Context

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

Real-World Impact

Hospitals may need to halt imaging procedures and coordinate with the manufacturer for replacement or service to prevent potential injuries.

Practical Guidance

How to identify if yours is affected

Verify device is a Maxicam dual-head gamma camera.
Check if serial number is within distribution scope (all serial numbers in distribution).
Compare device status with recall notice and FDA listing.

Where to find product info

Refer to the FDA enforcement report Z-0296-2026 and GE HealthCare recall communications.

What timeline to expect

Not specified by the recall notice.

If the manufacturer is unresponsive

Document outreach attempts and follow up with hospital biosafety or biomedical engineering.
Escalate to FDA recall coordinator if vendor is unresponsive.

How to prevent similar issues

Maintain detector mounting integrity during any movement.
Implement recall guidance for handling, transport, and relocation of imaging systems.
Ensure service providers are aware of recall and proper installation procedures.

Documentation advice

Keep copy of recall notice, serial numbers, distribution list, and all correspondence with GE HealthCare and hospital staff.

Product Details

Model numbers: Maxicam dual-head gamma camera. Sold to: Hospitals and clinics worldwide. When sold: Prior to recall date. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

37 units recalled
Global distribution
End of Guaranteed Service cited as trigger
Detector mounting risk
Life-threatening injury potential
Stop-use-immediately directive

View Original Recall on FDA - Medical Devices

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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

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.

Sep 12, 2025

GE HealthCare