Reported Apr 17, 2024 · Ongoing

PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to…

Philips North America

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 North America · 222 Jacobs St · Cambridge, MA · 02141-2296

Is this the product you have?

  • PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional
  • images of the body Model Number728143
Lot codes and dates
  • UDI-DI(01)00884838085015(21)
  • Serial Numbers

    428 of 428 codes

    • 500092
    • 500202
    • 500264
    • 500265
    • 33002
    • 500217
    • 500046
    • 33001
    • 33003
    • 500064
    • 500102
    • 500110
    • 500111
    • 500145
    • 500168
    • 500178
    • 500211
    • 500216
    • 500222
    • 500242
    • 500252
    • 500255
    • 500282
    • 500032
    • 500073
    • 500138
    • 500034
    • 500038
    • 500069
    • 500091
    • 500135
    • 500087
    • 500041
    • 500056
    • 500089
    • 500103
    • 500105
    • 500116
    • 500123
    • 500125
    • 500136
    • 500152
    • 500200
    • 500213
    • 500219
    • 500233
    • 500256
    • 500045
    • 500024
    • 500028
    • 500122
    • 500173
    • 500283
    • 500003
    • 500020
    • 500052
    • 500075
    • 500118
    • 500134
    • 500146
Amount recalled
428 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured

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

Data as of Sep 19, 5:37 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.