Reported Dec 12, 2018 · Terminated

Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce…

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 10 Slice (Air)
  • Model 728251 Product UsageComputed 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Lot codes and dates
  • System Serial Number

    79 of 79 codes

    • 2598
    • 3008
    • 3098
    • 4001
    • 4002
    • 4003
    • 4005
    • 4006
    • 4007
    • 4008
    • 4009
    • 4010
    • 4011
    • 4012
    • 4014
    • 4015
    • 4016
    • 4020
    • 4021
    • 4022
    • 4023
    • 4026
    • 4027
    • 4028
    • 4029
    • 4030
    • 4031
    • 4032
    • 4033
    • 4034
    • 4035
    • 4039
    • 4040
    • 4044
    • 4045
    • 4047
    • 4048
    • 4049
    • 4050
    • 4052
    • 4053
    • 4054
    • 4056
    • 4058
    • 4059
    • 4061
    • 4062
    • 4063
    • 4064
    • 4065
    • 4066
    • 4067
    • 30099
    • 40004
    • 40005
    • 40006
    • 40007
    • 40008
    • 40009
    • 40010
    728251_859-1766
Amount recalled
N/A

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

  • Nationwide

Why it was recalled

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 3, 2021 · Data as of Sep 19, 6:53 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.