Reported Apr 20, 2016 · Terminated

Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer…

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?

  • Brilliance iCT SP 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
Lot codes and dates
  • Model No. 728311
  • S/N
    • 200011
    • 200013
    • 200017
    • 200022
    • 200027
    • 200030
    • 200032
    • 200038
    • 200040
    • 200047
    • 200049
    • 200051
    • 200061
    • 200063
    • 200067
    • 200068
    • 200074
    • 200088
    • 200093
    • 200097
    • 200100
    • 200101
    • 200105
    • 200107
    • 200109
    • 200111
    • 200117
    • 200121
    • 200127
    • 200131
    • 200138
    • 200200
    • 200201
    • 200202
    • 200203
    • 200204
    • 200205
    • 200206
    • 200207
    • 200208
    • 200209
    • 200210 & 200211
Amount recalled
49 Units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

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

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips Medical Systems (Cleveland) Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 5:20 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.