Reported Aug 1, 2018 · Terminated
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
Brivo XR385model 5215463Digital Diagnostic Radiographic System
- Lot codes and dates
- Mfg Lot or Serial # /
- System ID
000A1E36N037X1 / 319668B385000A1E36N037X1 / GON4182034000A1E38N026L1 / 504EJLKV1000A1E38N026N2 / 907983BRIVO000A1E38N026R1 / 316630BRIVO000A1E38N026U2 / 319754B385000A1E38N026V1 / 860678BRIVO000A1E44N025A1 / 201567RAD1000A1E44N025G1 / 409295BRIVOXR000A1E44N025K2 / 860658XR385000A1E44N025O1 / 214MHXR385000A1E44N025V1 / 402384NHIRAD000A1E44N025Y1 / 256ODCRAD1000A1E44N025Z1 / 760323BRIVO1000A1E4BN003V2 / 772335B385000A1E4CN012F2 / 270737RAD1000A1E4CN012G1 / 804281XR385000A1E4CN012O1 / 240707RAD000A1E4CN012Q1 / 305MMC385000A1E4CN012T1 / 615396DR000A1E4CN076H2 / 203422BRIVO000A1E4CN076M1 / 856291BRIVO000A1E4CN076N1 / 808AAOMBRIVO000A1E4CN076R2 / 850325BC385000A1E4CN077P1 / 780875RAD000A1E4CN077R2 / 905850XR1000A1E4CN077V2 / 210INWD385ER000A1E52N024C2 / 623561XR385000A1E57N059P2 / 240707RAD000a1E57N060K2 / 813873BR1000A1E57N060L2 / 661KMSXR2000A1E57N060T2 / 707464BRIVO000A1E57N060W1 / 325655RAD000A1E57N060X1 / 973292BRIVO000A1E57N060X2 / 815464XR385000A1E57N060Y1 / 413447BRIVO000A1E5AN058C1 / 813906DR1000A1E5AN058D2 / 805898BRIVO1000A1E5AN058J1 / 508862BRIVO000A1E5AN058J2 / 575627BR385000A1E5AN058L1 / 671FHPBRIVO000A1E5AN058O2 / 508778XR385000A1E5AN058W1 / 541789BRIVO000A1E5AN058Y2 / 954PALMSXR000A1E5AN058Y2 / AM14GBU59000A1E5AN058Z1 / 415526BRIVO000A1E5AN059K1 / 306625XR385000A1E5AN059M2 / 662647BRIVO000A1E5AN059V2 / 575542BR385000A1E5AN059Y2 / PROVXR385000A1E5CN061G1 / 505609B385000A1E5CN061J1 / 863419BRI000A1E5CN061L1 / 404616BRIVO000A1E5CN061M1 / 615220PBRIVO000A1E5CN061V1 / 856355XR385000A1E5CN062H1 / 217774SXRA1E5AN058X1 / 508548XR385A1E67N001A2 / SLP385
- Amount recalled
- 58 (55 US, 3 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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