Class II U.S. Food and Drug Administration

Ge Medical Systems Israel, Functional Imaging Elscint SPX6 recall: GE HealthCare has become aware that certain Nuclear Medicine systems

Recall published 12 months ago

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.

The hazard: Fall or tip-over hazard

The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

What the notice says: 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.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0293-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Ge Medical Systems Israel, Functional Imaging
Product type
Medical devices
Units affected
28 units
Made in
Israel
Lot / code info
all serial numbers in distribution

Products covered by this recall

Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

What to do about Fall

Ge Medical Systems Israel, Functional Imaging — The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  3. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.
  4. Follow the remedy on this page; many of these recalls supply a free anchoring kit as well as a refund.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.

Company contact: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — 9, Andrey Sakharov, Haifa

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ge Medical Systems Israel, Functional Imaging medical… 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. 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…

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Related recalls