HIGH

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled 38 Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The affected systems may have been relocated without adequate support, risking serious injury. No incidents have been reported, but the recall is classified as a Class II hazard.

Quick Facts at a Glance

Recall Date
December 10, 2025
Hazard Level
HIGH
Brand
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 (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

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: Telephone

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About This Product

Nuclear Medicine systems are used for diagnostic imaging, allowing healthcare providers to visualize organ function and structure. These systems are critical in various medical settings, particularly in oncology and cardiology.

Why This Is Dangerous

The hazard arises from improper support during transport, which can lead to excessive stress on the detector mounting mechanisms. This could result in the detector falling, posing a serious injury risk to patients and healthcare staff.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall necessitates immediate action from healthcare providers to prevent potential injuries, impacting patient care and safety protocols.

Practical Guidance

How to identify if yours is affected

  1. Verify the model and serial number against the affected product list provided by GE HealthCare.
  2. Check the manufacturing date to confirm if it falls within the impacted range.
  3. Contact your healthcare facility's biomedical engineering department for assistance.

Where to find product info

The model and serial numbers can usually be found on the back or side of the device, or in the user manual.

What timeline to expect

Expect a response time of 4-6 weeks for follow-up instructions or refund processing.

If the manufacturer is unresponsive

  • Document your attempts to contact the manufacturer.
  • Reach out to the FDA for further guidance on the recall process.
  • Consider contacting a legal professional if the situation remains unresolved.

How to prevent similar issues

  • Ensure that any medical equipment is properly supported during transport.
  • Regularly review the manufacturer's service updates and recalls for any relevant information.
  • Consult with biomedical engineers on best practices for equipment handling.

Documentation advice

Keep a record of all correspondence related to the recall, including dates, times, and the names of individuals you spoke with.

Product Details

The recall affects 38 units of Nuclear Medicine systems from GE HealthCare. These systems are past their End of Guaranteed Service and have been distributed in the US, Canada, Brazil, and several European countries.

Key Facts

  • 38 units recalled
  • Potential for life-threatening injuries
  • Class II recall due to high hazard level
  • No reported incidents of falls or injuries
  • Contact manufacturer for further instructions

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
OTHER

Product Classification

Product Details

Model Numbers
UDI/DI Not applicable: All serial numbers in distribution
Report Date
January 21, 2026
Recall Status
ACTIVE

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