FDA recall Z-0352-2025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

Philips Zenition 50, Model Number: 718096

Reason for recall

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

Distribution

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 Kin

Key facts

Status
Ongoing
Initiation date
2024-10-07
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2025