Z-0302-2026Class II

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

Name: Z-0302-2026 Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed...
Creator: Ge Medical Systems Israel, Functional Imaging
Published: 2025-09-12
License: https://open.fda.gov/license/

GE Medical Systems Israel, Functional Imaging / initiated 2025-09-12 / Open, Classified / root cause: packaging

FDA source

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING began a recall of Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging on 2025-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0302-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-10-23
Recalling firm: GE Medical Systems Israel, Functional Imaging
Product: Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 9/12/2025 via letter (USPS first class). The notice explained the issue, potential safety issue, and requested the following: "Actions to be taken by Customer/User: You have previously been formally notified that these Impacted Systems have reached their End of Guaranteed Service life. GE HealthCare does not have the ability to correct these devices. GE HealthCare requests you to immediately STOP USING your Impacted System(s). As these devices are no longer supported and are no longer serviceable, continued use may compromise patient or user safety, negatively impact product performance, or introduce other risks to patients, users, and facilities. This is the final communication from GE HealthCare regarding these devices. Please ensure all potential users in your facility are made aware of this Stop Use safety notification. Take care when deinstalling the system, ensuring the system is balanced and all parts are secure. If you require assistance in removal and disposal of your system, please contact your local GE HealthCare representative. If you would like to discuss your replacement options, please contact your GE HealthCare account representative. Please retain this document for your records. Contact Information: If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." On 10/01/2025, the firm sent a follow-up notice removing Millenium VG from this action as it was erroneously included in the first notice.
Quantity in commerce: 205 units
Distribution: Worldwide
Product codes and lots: all serial numbers in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0302-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0291-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0292-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0293-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0294-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0295-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0296-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0297-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0298-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0299-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0300-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0301-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0302-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23
Z-0303-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code KPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)