Agency classClass IOur severity:Critical FDA (Devices)·Z-1790-2013·Announced 2013-07-31

GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death

GE Healthcare is recalling 13 Brivo NM615 nuclear medicine imaging systems worldwide after a patient died from injuries sustained during a scan on a related system.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that a patient died due to injuries sustained while being scanned on a related system, which meets the rubric criteria for a Critical severity score (known fatalities).

Plain-English summary

GE Healthcare, LLC is recalling 13 units of the Brivo NM615, an all-purpose, single detector integrated nuclear imaging system. The recall is being conducted because serious injuries or deaths could occur due to a failure mode associated with the device. The Brivo NM615 is intended for general nuclear medicine imaging procedures to detect the location and distribution of gamma ray photon emitting radionuclides in the body.

The recall was initiated after GE became aware of an incident at a US VA Medical Center facility where a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. The affected Brivo NM615 systems were distributed worldwide, including in the United States, Guam, Puerto Rico, and numerous international locations.

Hospitals and facilities using these systems should stop using the affected units immediately. GE notified hospitals of the recall on July 03, 2013. Users should contact GE Healthcare for further instructions on how to proceed with the recall.

The recalled product

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Nuclear Medicine Imaging
Hazard: patient-injury
device-failure
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

System ID: 030151NU17
387171NU01
405456NM615
406222LN615
478272NM
702304NM615
A5635609
HC0541NU03
HC3366NU02
NM24011
NM24015
ZA1819NM04
ZA2446NM01.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · GE Healthcare, LLC

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