Brilliance iCT SP recall: Software Issue
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Why was Brilliance iCT SP recalled?
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Brilliance iCT SP Model No. 728311 S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032, 200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067, 200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204, 200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209, 200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025, 200026,200041,200086,200102,200213
- Product
- Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 57 Units
- Distribution
- 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.
- Recall date
- August 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)