Reported Dec 12, 2018 · Terminated

Brilliance 16 Slice (Power), Model 728240 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 16 Slice (Power)
  • Model 728240 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

    206 of 206 codes

    • 3004
    • 3046
    • 3100
    • 3236
    • 3406
    • 3723
    • 5003
    • 5039
    • 5043
    • 5047
    • 5071
    • 5080
    • 5157
    • 5251
    • 5280
    • 5284
    • 5345
    • 5356
    • 5374
    • 5390
    • 5395
    • 5413
    • 5430
    • 5455
    • 5467
    • 5495
    • 5499
    • 5500
    • 5512
    • 5527
    • 5638
    • 5822
    • 6006
    • 6009
    • 6010
    • 6011
    • 6013
    • 6016
    • 6017
    • 6020
    • 6021
    • 6022
    • 6023
    • 6024
    • 6026
    • 6027
    • 6028
    • 6029
    • 6030
    • 6031
    • 6032
    • 6033
    • 6034
    • 6035
    • 6036
    • 6037
    • 6038
    • 6039
    • 6041
    • 6042
    NLCCT
Amount recalled
6,343 units in total

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, 4:53 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.