Reported Aug 14, 2019 · Terminated

Brilliance 64 Model # 728231, computed tomography x-ray system

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 64 Model # 728231, computed tomography x-ray system
Lot codes and dates
  • 204 of 204 codes

    • System Serial Number 335
    • 338
    • 1897
    • 4001
    • 4003
    • 4016
    • 4021
    • 9009
    • 9029-9030
    • 9033
    • 9035
    • 9038
    • 9040
    • 9045
    • 9047
    • 9048
    • 9052
    • 9054
    • 9056
    • 9058
    • 9062
    • 9064-9068
    • 9070-9077
    • 9080
    • 9086
    • 9087
    • 9089
    • 9092
    • 9093
    • 9098
    • 9099
    • 9104- 9108
    • 9112
    • 9117 9120
    • 9121
    • 9127
    • 9134
    • 9138
    • 9140
    • 9148
    • 9159- 9160
    • 9171
    • 9187
    • 9201
    • 9208
    • 9234
    • 9243
    • 9501
    • 9509 through 9608
    • 9610 through 10288
    • 10291 through 10327
    • 10330 through 10339
    • 10341 through 10808
    • 10811-10812
    • 29002
    • 29005
    • 29007
    • 29009
    • 29012
    • 29014
Amount recalled
582

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

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 Oct 6, 2022 · Data as of Sep 19, 6:06 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.