Reported Aug 17, 2016 · Terminated

Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.

Philips Medical Systems (Cleveland) Inc.

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: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Lot codes and dates
  • Ingenuity Core Model No. 728321
  • S/N

    314 of 314 codes

    • 31001
    • 52030
    • 52031
    • 52044
    • 52050
    • 310292
    • 333064
    • 52000
    • 52012
    • 52015
    • 52018
    • 52020
    • 52022
    • 52063
    • 310001
    • 310022
    • 310023
    • 310026
    • 310032
    • 310039
    • 310096
    • 310105
    • 310133
    • 310135
    • 310157
    • 310160
    • 310209
    • 310210
    • 310211
    • 310212
    • 310213
    • 310214
    • 310215
    • 310216
    • 310217
    • 310218
    • 310219
    • 310220
    • 310221
    • 310222
    • 310223
    • 310224
    • 310225
    • 310226
    • 310227
    • 310228
    • 310229
    • 310230
    • 310231
    • 310232
    • 310233
    • 310234
    • 310236
    • 310237
    • 310238
    • 310239
    • 310240
    • 310241
    • 310242
    • 310243
Amount recalled
276 Units

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Where it was sold

Why it was recalled

Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 2, 2018 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.