Welch Allyn, Inc. 901054 (REF 06000-300)Recalls & reported problems
Welch Allyn, Inc. · Braun Thermoscan Pro 6000 Ear Thermometer with Large Cradle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00732094309027), received between May 4, 2021 and Jan 10, 2024 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (13 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jun 13, 2024Class IIOpen, Classified
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
Z-2339-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jul 20, 2021Class IIOpen, Classified
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
Z-2482-2021 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Excessive Heating13
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Burning Sensation1
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED . THERE WERE NO ALLEGATIONS OF INJURY. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18483485 ↗MalfunctionJan 16, 2023Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16174950 ↗MalfunctionJan 9, 2023Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16120825 ↗MalfunctionDec 22, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED A NURSE WAS USING THE PRO 6000 THERMOMETER AND THE TIP/PROBE WAS HOT AND BURNED THE PATIENT¿S EAR. THE PATIENT FELT PAIN, BUT THERE WAS NO VISIBLE BURN MARK, AND THE CUSTOMER STATED THE PATIENT WAS NOT INJURED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #: (B)(4).
Patient problems: Pain
MAUDE report 16032797 ↗MalfunctionDec 22, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032591 ↗MalfunctionDec 22, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16032533 ↗MalfunctionJun 10, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED AND GAVE INACCURATE TEMPERATURE READINGS. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14652535 ↗MalfunctionMay 11, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14352862 ↗MalfunctionApr 21, 2022Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED AND SHOWED AN ERROR MESSAGE. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM REF # C-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167621 ↗MalfunctionNov 23, 2021Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THE PRO 6000 EAR THERMOMETER BURNED A PATIENT DURING USE. THE CUSTOMER DID NOT PROVIDE THE SEVERITY OF THE BURN AND MEDICAL INTERVENTION, IF ANY, WAS NOT REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT HAVE BEEN UNSUCCESSFUL. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: Burning Sensation
MAUDE report 12859757 ↗MalfunctionAug 10, 2021Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302196 ↗MalfunctionJul 23, 2021Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12217301 ↗MalfunctionMay 4, 2021Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 SMOKED/BURNED. THERE WERE NO ALLEGATIONS OF INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11769952 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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