Data Foundry

Medical device recalls 2015

BrightView model number: 882478 BrightView X model number: 882480… — Class II medical device recall Z-1011-2015

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-02-04, distributed nationwide. Unintended detector and gantry movement due to software issues.

Recall numberZ-1011-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2014-11-12
Classified2015-01-26
Reported by FDA2015-02-04
Terminated2018-07-02
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IR, IT, JP, KR, LB, LT, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA
Quantity1,064 units
Reason classessoftware
Model numbers882454, 882478, 882480, 882482

Product

BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

Reason for recall

Unintended detector and gantry movement due to software issues.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1011-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.