Welch Allyn Inc: 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

Recall number

Z-2482-2021

Recalling firm

Welch Allyn Inc

Product

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

Status

Open, Classified

Initiated

2021-07-20

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Labeling design

Action

Welch Allen (a Hill Rom company) issued Urgent Medical Device Correction Letter (FA-2021-05-001-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). The letter states reason for the Field Action, risk mitigations, and Actions to be taken by the User: 1. Please share this communication with all potential users in your organization and instruct them to follow the provided Cleaning Guide for proper cleaning. 2. Do 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. 3. Do 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. 4. If you experience an overheating probe tip, do not use the device and contact Hillrom Customer Service to report the issue. 5. Complete the attached response form and return to HillromSKF004@stericycle.com within one month. Actions to be taken by the distributor: Please share with end users and/or your accounts and complete the attached response form and return to HillromSKF004@stericycle.com within one month. Contact HillromSKF004@stericycle.com to receive an electronic copy of this notification, response form, and further instructions for notifying your accounts. Actions being taken by Hillrom: Hillrom is in the process of updating the Braun ThermoScan Pro 6000 Instructions for Use (IFU) to include additional fluid ingress warnings. The IFU and Cleaning Guide can be found on the Hillrom website, Hillrom.com, under the Education & Documentation section of the Braun ThermoScan PRO 6000 Products page. The updated IFU will be available on the website

Quantity

1,036,740 units

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, 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, Kuwait, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Monaco, Myanmar, N.Mariana Islnd, Netherlands (the), New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Utd.Arab Emir., Vietnam, Zimbabwe.

Lot, serial or model codes

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.

510(k) numbers

["K152748"]

PMA numbers

not on file

Product code

FLL

Firm FEI

1316463

Firm city

Skaneateles Falls

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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