Reported Jun 9, 2021 · Terminated
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model…
Philips North America LLC
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 Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body
- Model Number728306
- Lot codes and dates
- Serial Numbers
100100100434
- Serial Numbers
- Amount recalled
- 2 units (1 US and 1 OUS)
Where it was sold
- Nationwide
- NV
Why it was recalled
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
This product could cause temporary or reversible health problems — stop using it.
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