Brivo XR385 recall
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Why was Brivo XR385 recalled?
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 000A1E4CN076H2 / 203422BRIVO, 000A1E4CN076M1 / 856291BRIVO, 000A1E4CN076N1 / 808AAOMBRIVO, 000A1E4CN076R2 / 850325BC385, 000A1E4CN077P1 / 780875RAD, 000A1E4CN077R2 / 905850XR1, 000A1E4CN077V2 / 210INWD385ER, 000A1E52N024C2 / 623561XR385, 000A1E57N059P2 / 240707RAD, 000a1E57N060K2 / 813873BR1, 000A1E57N060L2 / 661KMSXR2, 000A1E57N060T2 / 707464BRIVO, 000A1E57N060W1 / 325655RAD, 000A1E57N060X1 / 973292BRIVO, 000A1E57N060X2 / 815464XR385, 000A1E57N060Y1 / 413447BRIVO, 000A1E5AN058C1 / 813906DR1, 000A1E5AN058D2 / 805898BRIVO1, 000A1E5AN058J1 / 508862BRIVO, 000A1E5AN058J2 / 575627BR385, 000A1E5AN058L1 / 671FHPBRIVO, 000A1E5AN058O2 / 508778XR385, 000A1E5AN058W1 / 541789BRIVO, 000A1E5AN058Y2 / 954PALMSXR, 000A1E5AN058Y2 / AM14GBU59, 000A1E5AN058Z1 / 415526BRIVO, 000A1E5AN059K1 / 306625XR385, 000A1E5AN059M2 / 662647BRIVO, 000A1E5AN059V2 / 575542BR385, 000A1E5AN059Y2 / PROVXR385, 000A1E5CN061G1 / 505609B385, 000A1E5CN061J1 / 863419BRI, 000A1E5CN061L1 / 404616BRIVO, 000A1E5CN061M1 / 615220PBRIVO, 000A1E5CN061V1 / 856355XR385, 000A1E5CN062H1 / 217774SXR, A1E5AN058X1 / 508548XR385, A1E67N001A2 / SLP385.
- Product
- Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 58 (55 US, 3 OUS)
- Distribution
- AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)