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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 produc
- Manufacturer
- GE Healthcare, LLC
- 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
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.
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