GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 2025-10-29 Health serious FDA
Health · FDA · Recall #FDA-Z-0293-2026
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac… Recall
Issued October 29, 2025 · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
In October 2025, GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalled the Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
- 1 Stop using Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Health
- Recall date
- October 29, 2025
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-0293-2026
- Made in
- Israel
- Issuing agency
- FDA
In context
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.