Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
Check against the official notice below — it lists the full affected range.
The Welch Allyn Braun ThermoScan PRO 6000 ear thermometer has been recalled worldwide because if the device is exposed to fluid ingress and used before cleaning fluid has completely dried, it may overheat and cause a burn to the user or the patient's ear canal. Approximately 1,036,740 units of this thermometer, which is used to measure body temperature in newborns and patients of all ages, are affected by this recall.
The recall affects all devices in distribution across the United States and numerous countries worldwide. The source does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
Reason for recall: If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient Distribution: Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Andorra, Australia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Canada, Chile, China, Colombia, Congo, Costa Rica, C¿te D'ivoire (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., Ecuador, Estonia, Finland, Franc Quantity: 1,036,740 units Lot/code info: All Devices in distribution. UDI: 00732094309027 DDDYYKXXXXX DDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234). YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13) K = KEYTRONIC XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.