The Recall Desk
HighFDA (Devices)·Z-0189-2015·Announced 2014-11-19

GE Healthcare Recalls Brivo NM615 Nuclear Imaging Systems Due to Loose Fasteners

GE Healthcare is recalling 22 Brivo NM615 nuclear imaging systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling equipment on a patient) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Healthcare, LLC is recalling 22 units of the Brivo NM615 all-purpose, single detector integrated nuclear imaging system. The recall involves specific models including H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, and H2401NJ. These systems are intended for general nuclear medicine imaging procedures to detect the location and distribution of gamma ray photon emitting radionuclides in the body.

The recall is being issued due to a potential safety issue where loose fasteners securing the camera to the gantry could cause a portion of the system to fall onto a patient during a scan. The affected units were distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, and DC) and numerous international locations such as Canada, the United Kingdom, Germany, and Japan.

GE Healthcare is updating the Preventative Maintenance procedure and schedule, which includes adding an additional check for loose fasteners on the Nuclear Medicine systems. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

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 inten
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Imaging System
Hazard
Affected units
22

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 6 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 6 products in this recall →

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