HIGH

GE Medical Systems Israel Varicam Gamma Camera Recall: 15 Units Worldwide (2025)

GE Medical Systems Israel recalls 15 Elscint Varicam dual-head gamma cameras worldwide. The recall cites a risk that devices moved without proper detector support, which could cause a detector fall. Clinicians should stop using the devices and follow manufacturer instructions immediately.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
GE Medical Systems Israel
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

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About This Product

The Elscint Varicam gamma camera is a dual-head imaging device used in nuclear medicine for cardiac imaging. It is typically deployed in clinical settings for diagnostic procedures.

Why This Is Dangerous

If moved without proper detector support, excessive stress can be placed on detector mounting mechanisms, risking detector detachment and bodily injury to patients and staff.

Industry Context

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

Real-World Impact

Hospitals may need to halt certain imaging procedures temporarily. The recall highlights the importance of proper equipment handling and service readiness for aging medical devices.

Practical Guidance

How to identify if yours is affected

  1. Identify if your facility uses an Elscint Varicam dual-head gamma camera.
  2. Check that the device is within distribution serial numbers scope (all serial numbers).
  3. Review service history and relocation records for the devices.
  4. Contact GE Medical Systems Israel, Functional Imaging for instructions.

Where to find product info

Recall notice and serial number guidance are available via FDA enforcement pages. Device serial numbers should be on the device nameplate and service records.

What timeline to expect

Remediation actions will be conducted as directed by the manufacturer. Replacement or service actions timelines will be communicated by GE Medical.

If the manufacturer is unresponsive

  • Escalate to the hospital biosafety officer or risk/compliance department.
  • File a report with the appropriate medical device regulatory body if necessary.
  • Maintain records of all correspondence with the manufacturer.

How to prevent similar issues

  • Maintain current service agreements and follow-up on End of Guaranteed Service status.
  • Do not relocate imaging equipment without manufacturer authorization.
  • Ensure detector mounting supports are intact and inspected during any transport.
  • Document all movements and handling of heavy medical imaging equipment.

Documentation advice

Keep the recall notification, device serial numbers, relocation logs, and all communications with the manufacturer for record-keeping.

Product Details

Model numbers: All serial numbers in distribution. Sold worldwide. Sold from: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 15 units recalled worldwide
  • Detector mounting risk could lead to detector fall
  • Past End of Guaranteed Service period
  • No injuries reported to date
  • Immediate action required: stop using the device and await manufacturer 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
FALL

Product Classification

Product TypeDual-head Nuclear Medicine Gamma Camera (Elscint Varicam)
Sold At
Unknown

Product Details

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

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