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
500092500202500264500265330025002175000463300133003500064500102500110500111500145500168500178500211500216500222500242500252500255500282500032500073500138500034500038500069500091500135500087500041500056500089500103500105500116500123500125500136500152500200500213500219500233500256500045500024500028500122500173500283500003500020500052500075500118500134500146
- 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.
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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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