Company: Philips Healthcare (Suzhou) Co., Ltd.
Date of Enforcement Report: 1/5/2024
Class II
PRODUCT
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Recall Number:
Z-0640-2024
REASON:
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operator’s voice are too quiet, patient can’t hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32×0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
RECALLING FIRM/MANUFACTURER:
Philips Healthcare (Suzhou) Co., Ltd.
VOLUME OF PRODUCT IN COMMERCE:
828
DISTRIBUTION:
Worldwide – US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan, Bolivia, Bosnia-Herz, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Mauritius, Moldova, Morocco, Netherlands, New Zealand, Norway, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Senegal, Serbia, Sint Maarten, Slovakia, South Africa, South Korea, Spain, St. Pier Miquel, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Venezuela, & Vietnam.
