Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Reported: August 17, 2016 Initiated: April 29, 2016 #Z-2385-2016
Product Description
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Reason for Recall
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 205 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 205 Units.
Why was this product recalled? ▼
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2385-2016.
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