Z-1046-2026Class II

SMV BodyTrack, System, Tomography, Computed, Emission

Name: Z-1046-2026 SMV BodyTrack, System, Tomography, Computed, Emission
Creator: Ge Medical Systems Israel, Functional Imaging
Published: 2025-12-10
License: https://open.fda.gov/license/

GE Medical Systems Israel, Functional Imaging / initiated 2025-12-10 / Open, Classified / root cause: packaging

FDA source

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING began a recall of SMV BodyTrack, System, Tomography, Computed, Emission on 2025-12-10. 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 (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter)...". 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-1046-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-10
Posted: 2026-01-09
Recalling firm: GE Medical Systems Israel, Functional Imaging
Product: SMV BodyTrack, System, Tomography, Computed, Emission
Product code: IYX Camera, Scintillation (Gamma)
Reason for recall: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: GE Healthcare began notifying their consignees by telephone on 12/10/2025, followed by an URGENT MEDICAL DEVICE CORRECTION UPDATE notice distributed on 01/05/2025 via US mail. The notice explained the issue, safety risk, and requested the consignee stop use of the product. Care should be exercised when deinstalling these systems. To discuss replacement options, your GE HealthCare account representative. Should be contacted.
Quantity in commerce: 12 units
Distribution: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
Product codes and lots: UDI/DI Not applicable: All serial numbers in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09
Z-1045-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09
Z-1046-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09
Z-1047-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09

Product code IYX

K911346Class ISophycamera Dsx BodytrakSopha Medical Systems, Inc. / cleared 1991-04-18

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)