HIGH

GE HealthCare Issues Recall of Nuclear Medicine Camera Due to Fall Risk

GE HealthCare recalled a dual-head nuclear medicine gamma camera on September 12, 2025, after identifying a risk of detector falls. One unit is affected, posing a high risk of life-threatening injury. Users must stop using the device immediately and follow manufacturer instructions.

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

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

Product Details

The recall affects the Optima NX dual-head nuclear medicine gamma camera. It was distributed worldwide and includes all serial numbers in distribution.

The Hazard

The camera may have been relocated without adequate detector support. This can stress the detector mounting mechanisms, risking a fall that could cause serious injuries.

Reported Incidents

Currently, no specific incidents have been reported. The potential for life-threatening injury exists if the detector falls.

What to Do

Immediately stop using the device. Contact GE Medical Systems Israel for further instructions regarding the recall.

Contact Information

For more information, visit the GE HealthCare website or contact your healthcare provider. Recall notifications are sent via letter.

Key Facts

  • Recall date: September 12, 2025
  • High hazard classification
  • One unit recalled
  • Worldwide distribution
  • Immediate action required

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
all serial numbers in distribution
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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