Skip to content
Recall Observatory FDA recall evidence

Device product

Braun Thermoscan¿ PRO 6000 Ear Thermometer

Z-2339-2024

June 13, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94825
Status
Ongoing
Classification
Class II
Quantity
265,647 units
Official record key
device-enforcement:Z-2339-2024

Official wording

Reason: The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

Code information: UDI: 00732094309003 (product code 06000-200) and 00732094309027 (product code 06000-300); All serial numbers.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).