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Class 2 Device Recall Brivo XR385 Stationary XRay System |
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Date Initiated by Firm |
September 16, 2016 |
Date Posted |
July 16, 2018 |
Recall Status1 |
Terminated 3 on July 26, 2018 |
Recall Number |
Z-2523-2018 |
Recall Event ID |
80486 |
510(K)Number |
K103448
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Product Classification |
System, x-ray, stationary - Product Code KPR
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Product |
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System |
Code Information |
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. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
800-437-1171
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Component change control |
Action |
An Important Electronic Product Radiation Warning letter was sent to consignees beginning 9/16/2016. The letter identified affected product, described the issue, and stated that GE will correct the devices without charge.
Questions can be directed to 1-800-437-1171. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = GE MEDICAL SYSTEMS, LLC
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