Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Elscint Model 4XX Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Due to GE HealthCare has become aware that certain Nuclear...

Date: September 12, 2025
Company: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING directly.

Affected Products

Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Quantity: 64 units

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide

About GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 41 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report