CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Ingenuity Core Computed Tomography X-ray systems is recalled
Philips Medical Systems (Cleveland) is recalling Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional, distributed in 46 states. The recall was initiated on 24 Mar 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-2371-2016
- FDA event ID
- 73750
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Mar 2016
- FDA classified
- 9 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 24 Mar 2016 | Recall initiated by company | |
| 9 Aug 2016 | Classified by FDA | +138 days |
| 17 Aug 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software defect causing intermittently slow response of Host.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Where it was distributed
Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional recalled?
Yes. Philips Medical Systems (Cleveland) recalled Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional on 24 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-2371-2016.
Why was it recalled?
Software defect causing intermittently slow response of Host.
Which lots are affected?
Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.
Where was it sold?
Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems (Cleveland)
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Packaging Defects | Nationwide |
| Device | CLASS II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |