FDA Device recall Z-1257-2019
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear me…
- FDA Device
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear me… 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-1257-2019 |
| 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 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
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 # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH…Mfg. Lot or Serial # System ID Model, Catalogue or Code # 63GY50074 334287NM630 H3101RH 63GX50024 501450D630 H3101RH 630X22925 310657D630 H3100JY 630X22921 951682NMDISC H3100JY 63GY50067 719776DISCNM H3101RH 63GX50001 863494NM H3101RH 630X22923 904296NM H3100JY 63GX50037 305223D630A H3101RH 63GX50060 305223D630B H3101RH 63GX50034 478289DIS H3101RH 63GX50014 618998NM H3101RH 63GX50019 270745NM1 H3101RH 63GY50078 269966NMDISC H3101RH 63GX50021 906225CARDNM2 H3101RH 63GX50022 906225CARDNM1 H3101RH 63GX50018 269637NM630 H3101RH 63GX50009 NM555658 H3101RH 63GY50080 4695517NM11 H3101RH 63GY50077 919954NMDISC H3101RH 63GX50043 828286RHD630 H3101RH 63GX50020 402481D630C H3101RH 63GX50040 973450CARD630 H3101RH 63GX50054 973450D630 H3101RH 63GX50008 856641NM H3101RH 63GY50079 SHIPPED (GON 4722927) H3101RH 63GX50061 702962NM1 H3101RH 63GX50035 702962NM2 5376204-31 63GX50050 702388DISC H3101RH 63GX50062 702724DISCNM H3101RH 63GX50032 513861NM H3101RH 63GX50055 513861 |
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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-1257-2019%22
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