Reported Aug 17, 2016 · Terminated

Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by…

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 CT 16 Power Computed Tomography X-ray systems is 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 #: 728240
    • Serial #s: 3100
    • 3236
    • 5043
    • 5047
    • 5280
    • 5345
    • 5390
    • 5395
    • 5413
    • 5430
    • 5476
    • 5495
    • 5499
    • 5500
    • 5512
    • 6007
    • 6009
    • 6013
    • 6032
    • 6041
    • 6045
    • 6049
    • 6051
    • 6058
    • 6062
    • 6064
    • 6066
    • 6067
    • 6070
    • 6071
    • 6077
    • 6080
    • 6081
    • 6084
    • 6089
    • 6095
    • 6098
    • 6100
    • 6106
    • 6109
    • 6113
    • 6115
    • 6116
    • 6119
    • 6120
    • 6123
    • 6124
    • 6131
    • 6132
    • 6134
    • 6141
    • 6144
    • 6155
    • 6161
    • 6162
Amount recalled
55 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 defect causing intermittently slow response of Host.

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, 6:02 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.