FDA-Device2024-11-20Class II
Philips Zenition 70, Model Number: 718133
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Sold states
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.
Affected count
2,247 units (582 US, 84 Canada, 1,581 R.O.W.)
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Philips Zenition 70, Model Number: 718133
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief