Brivo XR385…

Date

Aug. 1, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

Reason

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.

Distribution pattern

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.

Quantity

58 (55 US, 3 OUS)

Codes and lots

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.

Recall started

Sept. 16, 2016

Device type

System, X-Ray, Stationary

Root cause (FDA)

Component change control

What the company told customers

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.

Recall number

Z-2523-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2523-2018. The agency record governs; check it and the company before acting.