Reported Feb 14, 2024 · Ongoing

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

Philips Medical Systems

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 · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • Spectral CT 7500Software Version 5.0
  • Model 728333 and Spectral CT 7500 China
    • Software Version 5.0
    • Model 728340
Lot codes and dates
  • UDI-DI
    • 00884838101111
    • Model 728333
  • serial numbers

    178 of 178 codes

    • 10197
    • 10182
    • 10175
    • 10192
    • 10179
    • 10196
    • 10180
    • 10188
    • 10190
    • 10181
    • 10183
    • 10178
    • 10186
    • 10185
    • 10199
    • 10184
    • 10198
    • 10193
    • 10187
    • 10189
    • 10195
    • 10191
    • 10194
    • 10018
    • 10023
    • 10027
    • 10062
    • 10072
    • 10078
    • 10079
    • 10080
    • 10084
    • 10088
    • 10101
    • 10104
    • 10112
    • 10117
    • 10113
    • 10116
    • 10032
    • 10049
    • 10133
    • 10140
    • 10152
    • 10153
    • 10166
    • 10170
    • 10171
    • 10173
    • 10172
    • 10174
    • 10016
    • 10015
    • 10017
    • 10019
    • 10022
    • 10021
    • 10020
    • 10025
    • 10024
  • Model728340
  • serial numbers
    • 397022
    • 397023
    • 397020
    • 397024
    • 397021
    • 397025
    • 397027
    • 397031
    • 397026
    • 397033
    • 397032
    • 397030
    • 397028
    • 397029
    • 397015
    • 397016
    • 397004
    • 397007
    • 397005
    • 397002
    • 397006
    • 397008
    • 397010
    • 397003
    • 397011
    • 397013
    • 397009
    • 397012
    • 397014
    • 397017
    • 397019
    • 397018
Amount recalled
US: 33, OUS 177

This recall covers 2 products

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

Where it was sold

Why it was recalled

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

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

Data as of Sep 19, 4:16 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.