Reported Oct 8, 2014 · Terminated
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to…
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?
- The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
- Lot codes and dates
- Ingenuity CT
728326 300005300010300012300016300017300019300020300021300028300029300031300032300033300035300037300039300043300047300050300051300052300054300055300057300060300061300062300063300072300074300082300086300087300089300094300095300100300101300102300106300108300110300112300113300129300135300136300140300143
- Ingenuity Core
728321 310001310002310009310055310059310064310069310070310087333015
- Ingenuity Core128
728323 300137320003320005320006320018320024320029320030320033320037320078320092320099320103320114336011336012336013336016336018
- Ingenuity CT
- Amount recalled
- 79
Where it was sold
Why it was recalled
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
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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