FDA-Device2024-07-17Class II
Braun Thermoscan¿ PRO 6000 Ear Thermometer
Baxter Healthcare Corporation
Hazard
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
Sold states
Distributed to United States, Canada, Australia, Malaysia, New Zealand, Philippines, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, and United Kingdom. UPDATED PER EMAIL DATED 7/24/2024: United States (including Puerto Rico and Guam), Canada, Australia, Brunei, Hong Kong, India, Korea, Malaysia, Maldives, Myanmar, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Afghanistan, Austria, Bahrain, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Luxemburg, Namibia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Yemen, Bahamas, Bolivia, Chile, Colombia, Ecuador, Guatemala, Mexico, and Panama.
Affected count
265,647 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Braun Thermoscan¿ PRO 6000 Ear Thermometer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2024Don't want to check this manually?
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