CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
Brivo XR385 recalled by GE Healthcare
GE Healthcare is recalling Brivo XR385, distributed in 23 states. The recall was initiated on 16 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2523-2018
- FDA event ID
- 80486
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2016
- FDA classified
- 20 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 16 Sep 2016 | Recall initiated by company | |
| 20 Jul 2018 | Classified by FDA | +672 days |
| 1 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Where it was distributed
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.
AlaskaAlabamaArizonaCaliforniaConnecticutFloridaGeorgiaHawaiiIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMississippiNew JerseyNew MexicoOregonPennsylvania
Questions about this recall
Why was it 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.
Which lots 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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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