Brilliance iCT and Brilliance iCT SP These systems are intended to… — Class II medical device recall Z-0831-2014

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-02-05, distributed nationwide. An artifact that resembles thrombus may appear on the image.

Recall number	`Z-0831-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated	2013-07-16
Classified	2014-01-27
Reported by FDA	2014-02-05
Terminated	2014-09-19
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, LB, NL, NO, NZ, OM, PA, PH, PL, QA, RO, RU, SA, SE, SG, TH, TR, TW
Quantity	506
Model numbers	`100016`, `100018`, `100019`, `100020`, `100021`, `100022`, `100023`, `100024`, `100025`, `100028`, `100031`, `100032`, `100037`, `100038`, `100039`, `100040`, `100042`, `100043`, `100044`, `100045`, `100046`, `100047`, `100048`, `100049`, `100050` and 475 more

Product

Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

Reason for recall

An artifact that resembles thrombus may appear on the image.

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-0831-2014. 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.