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.
What this means for you
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
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
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