Ingenuity Core 128 Computed Tomography X-ray Systems — Class II medical device recall Z-1355-2016

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-04-20, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The firm was notified of a software error in which the system may not automatically send all image/data series

Recall number	`Z-1355-2016`
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	2016-02-05
Classified	2016-04-08
Reported by FDA	2016-04-20
Terminated	2018-07-02
Distributed	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV
Countries outside the US	AE, AF, AT, AU, BD, BE, BR, CA, CH, CN, DE, DK, EG, ES, FI, FR, GB, GH, GR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, LB, LT, MX, NL, NO, NZ, OM, PH, PL, RO, SE, SG, TH, TW, UA, VN
Quantity	174 units
Reason classes	software
Model numbers	`728323`

Product

Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Reason for recall

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

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-1355-2016. 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.