FDA Medical Device Recalls (openFDA)
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Recall number
- Z-0291-2026
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product
- Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Status
- Open, Classified
- Initiated
- 2025-09-12
- Posted
- 2025-10-23
- Terminated
- not on file
- Reason
- 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
- 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
- 64 units
- Distribution
- Worldwide
- Lot, serial or model codes
- all serial numbers in distribution
- 510(k) numbers
- ["K884674"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 3027338963
- Firm city
- Haifa
- 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