FDA-Device2023-09-06Class II
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
Loss of availability of the wireless foot switch during procedures.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kosovo, Latvia, Lebanon, Libya, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen.
Affected count
1865 units
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2023Don'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