Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion
Mexico, Monaco, Myanmar, N.Mariana Islnd, Netherlands (the), New Zealand, Norway, Kuwait, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Malta, Martinique, Worldwide distribution - US Nationwide distribution and the countries of Afghanistan,Īndorra, Australia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Canada, Chile, China,Ĭolombia, Congo, Costa Rica, C¿te D'ivoire (Ivory Coast), Croatia, Cyprus, Czech Republic,ĭenmark, Dominican Rep., Ecuador, Estonia, Finland, France, Frenc.Polynesia, French, Guiana, Germany, Greece, Guadeloupe, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, The updated IFU will be available on the website
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The IFU and Cleaning Guide can be found on the Hillrom website,, under the Education & Documentation section of the Braun ThermoScan PRO 6000 Products page. Hillrom is in the process of updating the Braun ThermoScan Pro 6000 Instructions for Use (IFU) to include additional fluid ingress warnings. Please share with end users and/or your accounts and complete the attached response form and return to within one month.Ĭontact to receive an electronic copy of this notification, response form, and further instructions for notifying your accounts. If you experience an overheating probe tip, do not use the device and contact Hillrom Customer Service to report the issue.ĥ.Ĝomplete the attached response form and return to within one month. Please share this communication with all potential users in your organization and instruct them to follow the provided Cleaning Guide for proper cleaning.Ģ.ĝo not use the device if the ring around the measurement button shows a green blinking or flashing light instead of a ready state (solid green light) and contact Hillrom Customer Service to report this issue.ģ.ĝo not use the device if the device requires multiple power-ups prior to going to ready state (solid green light) and contact Hillrom Customer Service to report this issue.Ĥ. The letter states reason for the Field Action, risk mitigations, andġ. Welch Allen (a Hill Rom company) issued Urgent Medical Device Correction Letter (FA-1-SKF-004) on 7/30/21 to: Chief Executive Facility Administrator Facility Engineer Vigilance Manager Biomedical Engineering Medical Device Liaison Officer Distributor mailed (with signature service) to all first-level consignees by Sedgwick (third party recall company). 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 XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER.
YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13)
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Thermometer, electronic, clinical - Product Code FLLīraun 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.ĭDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234).
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