FDA Recall Terminated

Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

Recall: Z-2381-2016 · Initiated April 29, 2016

Recall

Recall Number
Z-2381-2016
Event Number
74131
Firm
Philips Medical Systems (Cleveland) Inc
FEI Number
1525965
Product Code
JAK
Status
Terminated
Root Cause
Software design
Initiated
April 29, 2016
Terminated
July 2, 2018
Address
595 Miner Rd, Cleveland, OH, 44143-2131

Description

Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

Reason

Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.

Action

The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.

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.

Quantity

335 Units