CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report

Sopha Medical Vision (Smv) DSXi/Dst-XLi,/ Dst-xl/ DSTi recalled

GE Medical Systems Israel Functional Imaging is recalling Sopha Medical Vision (Smv) DSXi/Dst-XLi,/ Dst-xl/ DSTi. The recall was initiated on 12 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers in distribution

Quantity recalled205 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0302-2026
FDA event ID: 97647
Recalling firm: GE Medical Systems Israel Functional Imaging, Haifa
Classification: Class II
Status: Ongoing
Recall initiated: 12 Sep 2025
FDA classified: 23 Oct 2025
Reported: 29 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

12 Sep 2025	Recall initiated by company
23 Oct 2025	Classified by FDA	+41 days
29 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

all serial numbers in distribution

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 97647

This product is part of a recall event; the main page for the event is Elscint SPX6 recalled by Ge Medical Systems Israel.

Reported	Class	Recall	Company	Reason
29 Oct 2025	CLASS II	Elscint SPX6 recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Millenium MPR recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Elscint Model 4XX; dual-head nuclear medicine gamma camera designed recalled	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Millenium MG/MC; dual-head nuclear medicine gamma camera recalled	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Millenium Myosight recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Starcam/Camstar recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Elscint Helix recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Elscint SPX4 recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Elscint Varicam recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Millenium MPS recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Elscint Cardial recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Maxicam; dual-head nuclear medicine gamma camera designed recalled	GE Medical Systems Israel Functional Imaging	Other
29 Oct 2025	CLASS II	Optima NX; dual-head nuclear medicine gamma camera designed recalled	GE Medical Systems Israel Functional Imaging	Other

More recalls from GE Medical Systems Israel Functional Imaging

All 41

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	GE Healthcare Omni Legend, sold under the following names recalled	GE Medical Systems Israel Functional Imaging	Other	Nationwide
21 Jan 2026Device	CLASS II	Maxxus, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV DSX New Line, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV BodyTrack, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV DSI, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other

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