Welch Allyn, Inc. 901054 (REF 06000-200)Recalls & reported problems
Welch Allyn, Inc. · Braun Thermoscan Pro 6000 Ear Thermometer with Small Cradle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Braun Thermoscan ear thermometer is an electronic ear thermometer used for clinical temperature readings. Most of its 221 reports describe the probe tip overheating, with no deaths or injuries reported. No reports were filed in the last 12 months, compared with 12 in the year before. There is 1 open recall, which began in June 2024 over thermometers shipped with an outdated instructions-for-use CD.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 221
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 00732094309003), received between Apr 28, 2021 and Jul 3, 2025 — classified as 221 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (217 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K152748); they may or may not involve this specific model.
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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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 ↗
Most reported problems
Device problems
- Excessive Heating217
- Overheating of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions211
- Superficial (First Degree) Burn5
- Burning Sensation2
- Blister1
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 221 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394246 ↗MalfunctionJul 3, 2025Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394163 ↗MalfunctionJun 12, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER BAXTER COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192278 ↗MalfunctionJun 11, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER BAXTER COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183087 ↗MalfunctionMay 21, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059865 ↗MalfunctionMay 19, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043287 ↗MalfunctionMay 19, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043163 ↗MalfunctionMar 24, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD #C-2343836.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676350 ↗MalfunctionJan 22, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER BAXTER COMPLAINT RECORD: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206220 ↗MalfunctionJan 9, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER BAXTER COMPLAINT RECORD (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21109572 ↗MalfunctionJan 8, 2025Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21100094 ↗MalfunctionJan 2, 2025Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21053080 ↗MalfunctionOct 25, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO 6000 OVERHEATED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531352 ↗MalfunctionOct 20, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490111 ↗MalfunctionOct 18, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482676 ↗MalfunctionOct 18, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20481005 ↗MalfunctionOct 18, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20479355 ↗MalfunctionOct 16, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462190 ↗MalfunctionOct 16, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461203 ↗MalfunctionOct 15, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450893 ↗MalfunctionOct 8, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395487 ↗MalfunctionOct 8, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395407 ↗MalfunctionOct 1, 2024Excessive Heating; Excessive Heating
THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT RECORD # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20342674 ↗MalfunctionSep 24, 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 20289839 ↗MalfunctionSep 13, 2024Excessive Heating; Excessive Heating
CUSTOMER REPORTED PROBE TIP HOT. 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 20216326 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152748. One submission often covers many models, so check the product and lot details in each record.
- Z-2482-2021 · Jul 20, 2021 · Open, ClassifiedBraun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newbo
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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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