FDA Device recall Z-1260-2019
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health…
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health… by Ge Healthcare, citing during installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1260-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-20 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:
Reason
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
Identifiers
| code_info | Mfg. Lot or Serial # System ID Model, Catalogue or Code # ESDX35020 403777D670C H3100BL ESPX54001 A51773134 H3100BM ESPY54002 DE203284 H3100BM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1260-2019%22
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