Reported Dec 30, 2015 · Terminated
Ingenuity Core Computed Tomography X-ray system
Philips Medical Systems (Cleveland) Inc.
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 (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core Computed Tomography X-ray system
- Lot codes and dates
- Model No. 728321
- S/N
133 of 133 codes
52007520085201052013520145201552018520195202052021520245202752032520335203452035520365203752038520405204152042520455204652047520485205152053520555205752058520605206452065520675206852069520705207552078310017310026310039310042310052310055310059310064310069310071310081310088310098310111310113310119310121310133310143310144
- Amount recalled
- 135 Units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
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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