FDA-Device2024-06-12Class II
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
Philips North America Llc
Hazard
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
Affected count
100 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2024Don't want to check this manually?
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