Reported Apr 8, 2015 · Terminated
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP,…
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?
- Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
- Lot codes and dates
- Brilliance iCT728306
- Serial Numbers
850128501385014100029100038100040100053100058100094100099100133100140100162100178100236100244100373100399100408100411100416100441100450100454100461100463100465100466100498100503100506100507100508100509100511100512100517 & 100518
- Brilliance iCT SP728311
- Serial Numbers200047 & 200121
- Ingenuity Core728321
- Serial Numbers
81 of 81 codes
310015200752008520105201252013520185202052021520245202652030520315203252033520345203552036520375203852039520425204352046520525205352054520555205752058310001310002310003310009310017310052310055310059310064310069310070310071310081310087310088310096310111310113310119310121310129310133310134310141310143310144310149310151310157310160
- Ingenuity Core128728323
- Serial Numbers
138 of 138 codes
320103201332015320163201832021320243202632032320333203432036320373204132042320433204432046320473204832049320513205232053320543205532057320593206032062320643206532067320683206932070320723207332074320753207732078320793208032082320833208432085320873208932090320913209232094320953210032101321033210432106
- Ingenuity CT728326
- Serial Numbers
158 of 158 codes
300033000430005300063000730008300093001130012300133001530018300193002030025320863209332107520235204452051300003300004300005300010300011300012300013300014300016300017300019300020300021300024300025300027300028300029300031300032300033300034300035300036300037300039300040300041300042300043300044300045300047300049300050300051300052300053300054
- Amount recalled
- 424 units
Where it was sold
Why it was recalled
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
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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