FDA Device recall Z-1790-2013
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system
- FDA Device
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system by Ge Healthcare, citing GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1790-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-13 |
| Published | 2013-07-31 |
| 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. 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 became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Identifiers
| code_info | System ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01. |
|---|
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-1790-2013%22
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