Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Nuclear Imaging System
Hazard: falling-object
impact-injury
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 →

Same manufacturer · GE Healthcare, LLC

See all →

High
GE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
High
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
High
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
High
GE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
Severe
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27

Same hazard · falling object