Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
Reported: April 8, 2015 Initiated: February 5, 2015 #Z-1359-2015
Product Description
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
Reason for Recall
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 424 units
- Distribution
- Worldwide Distribution - Nationwide Distribution to the states of : AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV and WY., and to the countries of : Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Cambodia, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jumeirah, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Training, Tunisia, Turkey, United Arab Emirates,United Kingdom, Uzbekistan and Viet Nam.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 424 units.
Why was this product recalled? ▼
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2015. Severity: Moderate. Recall number: Z-1359-2015.
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