Reported Aug 14, 2019 · Terminated
Ingenuity Core Model # 728321, 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 Model # 728321, computed tomography x-ray system
- Lot codes and dates
System Serial Number 106343100152000- 5200152003- 5200452006 through 52022 52024- 5202752029 through 5207352075 through 5210252104 through 5215852160- 52161957269573895739100827122416200090300087300095300155310001- 310002310006- 310008310009- 310010310012 through 310018310020 through 310026310028 through 310035310037 through 310166310168310170 -310172310203 through 310413333001 through 333028333030- 333032333035 - 333039333041 through 333063333065 through 333127333129 through 333159333163 through 333218338001- 33800331000163100503101213100503101253330723331013331653331705207552078
- Amount recalled
- 202
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
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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