CLASS II Device recall · Reported 12 Oct 2016 · FDA Enforcement Report
Ingenuity Core recalled by Philips Medical Systems
Philips Medical Systems is recalling Ingenuity Core 128, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0011-2017
- FDA event ID
- 75157
- Recalling firm
- Philips Medical Systems, Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 3 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 3 Oct 2016 | Classified by FDA | +40 days |
| 12 Oct 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Product as listed by the FDA
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Which lots are affected?
30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32171, 32173, 52023, 52028, 52049, 52073, 320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211, 320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320253, 320254, 320255, 320256, 320257, 320258, 320259, 320260, 320261, 320262, 320263, 320264, 320265, 320266, 320267, 320268, 320269, 320270, 320271, 320272, 320273, 320274, 320275, 320276, 320278, 320279, 320280, 320281, 320282, 320283, 320284, 320285, 320286, 320288, 320289, 320290, 320291, 320292, 320293, 320295, 320296, 320297, 320298, 320299, 320301, 320302, 320303, 320305, 320307, 320309, 320310, 320311, 320312, 320313, 336011, 336012, 336013, 336015, 336016, 336017, 336018, 336023, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336046, 336051, 336059, 336060, 336064, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336073, 336075, 336076, 336077, 336078, 336079, 336080, 336081, 336082, 336083, 336084, 336085, 336086, 336087, 336088, 336089, 336090, 336091, 336092, 336093, 336094, 336095, 336096, 336097, 336098, 336099, 336100, 336101, 336102, 336103, 336104, 336105, 336106, 336107, 336108, 336109, 336110, 336111, 336112, 336113, 336114, 336115, 336116, 336117, 336118, 336119, 336120, 336122, 336123, 336124, 336125, 336126, 336127, 336128, 336129, 336130, 336131, 336132, 336133, 336134, 336135, 336136, 336137, 336138, 336139, 336140, 336141, 336142, 336143, 336144, 336145, 336146, 336147, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336165, 336166, 336167, 336168, 336169, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336179, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336187, 336188, 336189, 336190, 336191, 336192, 336193, 336194, 336195, 336196, 336197, 336198, 336199, 336200, 336201, 336202, 336203, 336204, 336205, 336206, 336207, 336208, 336209, 336210, 336211, 336212, 336213, 336214, 336215, 336216, 336217, 336218, 336219, 336220, 336221, 336222, 336223, 336224, 336225, 336226, 336227, 336228, 336229, 336230, 336231, 336232, 336234, 336235, 336236, 336241, 336243, 336245, 336246, 336247, 336248, 336249, 336252, 336256, 336781, 336782, 336783, 336784, 336785, 336786, 336787, 336788, 336789, 336790, 336791
Where was it sold?
Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 75157This product is part of a recall event; the main page for the event is Ingenuity Core recalled by Philips Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ingenuity Core recalled by Philips Medical Systems | Philips Medical Systems | Other | Nationwide | |
| CLASS II | Ingenuity CT recalled by Philips Medical Systems | Philips Medical Systems | Other | Nationwide | |
| CLASS II | Brilliance 64 CT Model Number 728231 Product Usage: Computed recalled | Philips Medical Systems | Other | Nationwide |
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|---|---|---|---|---|---|
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |