CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Brilliance 64 CT Model 728231; To produce cross-sectional images recalled
Philips Medical Systems (Cleveland) is recalling Brilliance 64 CT Model 728231; To produce cross-sectional images of, distributed in 45 states. The recall was initiated on 29 Apr 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-2380-2016
- FDA event ID
- 74131
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2016
- FDA classified
- 10 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2016 | Recall initiated by company | |
| 10 Aug 2016 | Classified by FDA | +103 days |
| 17 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
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
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Where it was distributed
Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
Which lots are affected?
Model No. 728231, Brilliance 64 CT S/N: 9099,9134,9251,9515,9646,9822,9898,9983,10099,10180,10206,10208,91003,95130,95157,95387,95504,4001,9056,9074,9529 9538,9549,9554,9573,9574,9618,9625,9638,9653,9656, 9659,9667,9670,9686,9689,9703,9738,9740,9755,9782,9811, 9833,9837,9838,9859,9862,9901,9909,9910,9917,9920,9923,9927,9930,9933,9989,9993,10021,10024,10042,10047,10050,, 10051,10077,10092,10106,10150,10193,10213, 10250,10299,10379,10394,10422,10671,10698 29002,29014,29056,29107,29115,90124,90154,95022,95024,95191,95197,95222,95236,95258,95261,95351,95364,95399,95410,95475,95496,95507,95512,95524,95551,95563,95614,95616, 95668,95688,95691,95707,95811,95341A,9541,9548,9559,9561,9600,9631,9678,9711,9763,9805, 9890, 9922, 10012, 10014, 10179,10216,10302,10446,10470,10514,10610,10743,95239,95244,95343,95349,95374,95409,95439 95538, 300062,122921,123092,123096,123116,123117,29015,5169, 9367,9640,9997,123029
Where was it sold?
Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & 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
5 other products · FDA event 74131More recalls from Philips Medical Systems (Cleveland)
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|---|---|---|---|---|---|
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