Reported Aug 9, 2023 · Ongoing
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
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?
- Incisive CT Power (China)-Computed
- Tomography X-Ray System Model728148
- Lot codes and dates
- UDI-DI(01)00884838103467 (21)
- Serial Numbers
530456530338530360530489530370530363530389530369530481530350530464530500530436530301530501530372530466530368530476530358530294530421530435530480530458530342530432530419530460530502530349530475530482530431530335530378530494530492530470530345530461530374530384530388530357530404530329530373530409530462530420530452530307
- Amount recalled
- 53 units OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
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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