FDA Medical Device Recalls (openFDA)
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: SMV BodyTrack, System, Tomography, Computed, Emission
- Recall number
- Z-1046-2026
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product
- SMV BodyTrack, System, Tomography, Computed, Emission
- Status
- Open, Classified
- Initiated
- 2025-12-10
- Posted
- 2026-01-09
- Terminated
- not on file
- Reason
- 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
- 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
- 12 units
- Distribution
- US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
- Lot, serial or model codes
- UDI/DI Not applicable: All serial numbers in distribution
- 510(k) numbers
- ["K911346"]
- PMA numbers
- not on file
- Product code
- IYX
- Firm FEI
- 3004571294
- Firm city
- Tirat Carmel
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28