FDA Device recall Z-0189-2015
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system by Ge Healthcare, citing GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0189-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories
Reason
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Identifiers
| code_info | Mfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM6…Mfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM615 24019 030151NU17 24011 NM24011 24014 NM24014 24020 NM24020 24015 NM24015 24016 GON1427120 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 24007 083026241010212 00000000116BH4 083026040018413 00000000117BH2 083026020020313 24008 A5635609 24017 NM24017 00000000084BH4 PK1267NM01 24005 ZA2446NM01 24012 ZA1819NM04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0189-2015%22
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