FDA Device recall Z-1264-2019
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine…
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine… 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-1264-2019 |
| 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
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
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 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 1…Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 190020NU01 87CX63006 030240NU11 87CX63015 705743NM870 87CX63011 M4184879 87CX63003 M9886873 87CX63004 X171582003 87CX63009 M171582018 87CX63010 UC1796NU01 87CX63013 NO1068MN18 87CX63005 A004NU20 87CX63002 C028NU01 87CX63012 C028NU02 87CX63001 900010NU12 |
|---|
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-1264-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.