Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2523-2018·Announced 2018-08-01

GE Healthcare Recalls Brivo XR385 Digital Radiographic Systems

GE Healthcare is recalling 58 Brivo XR385 digital radiographic systems because placing weight on the detector can cause image artifacts, leading to patient exam retakes.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard results in image artifacts and exam retakes without reporting any injuries or illnesses. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.

Plain-English summary

GE Healthcare, LLC is recalling 58 units of the Brivo XR385, model 5215463, Digital Diagnostic Radiographic System. The recall covers 55 units in the United States and 3 units outside the US. The systems were distributed across 25 US states, Guam, and Canada.

The recall is due to a defect where placing weight on the VRAD detector can introduce image artifacts. These artifacts can result in the need for patient exam retakes. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities that have purchased these systems should contact GE Healthcare for instructions on how to resolve the issue. The recall number is Z-2523-2018.

The recalled product

Product: Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Radiographic System
Hazard: image-artifacts
exam-retake

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 (20)

Mfg Lot or Serial # / System ID: 000A1E36N037X1 / 319668B385
000A1E36N037X1 / GON4182034
000A1E38N026L1 / 504EJLKV1
000A1E38N026N2 / 907983BRIVO
000A1E38N026R1 / 316630BRIVO
000A1E38N026U2 / 319754B385
000A1E38N026V1 / 860678BRIVO
000A1E44N025A1 / 201567RAD1
000A1E44N025G1 / 409295BRIVOXR
000A1E44N025K2 / 860658XR385
000A1E44N025O1 / 214MHXR385
000A1E44N025V1 / 402384NHIRAD
000A1E44N025Y1 / 256ODCRAD1
000A1E44N025Z1 / 760323BRIVO1
000A1E4BN003V2 / 772335B385
000A1E4CN012F2 / 270737RAD1
000A1E4CN012G1 / 804281XR385
000A1E4CN012O1 / 240707RAD
000A1E4CN012Q1 / 305MMC385
000A1E4CN012T1 / 615396DR

Distribution

Distributed in 24 states:

Same manufacturer · GE Healthcare, LLC

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