Recall Z-2482-2021— Welch Allyn Inc
Class II · Ongoing
Class II FDA medical device recall by Welch Allyn Inc, initiated 2021-07-20. It names one FDA 510(k) clearance: K152748. 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. 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.
- Recalling firm
- Welch Allyn Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-07-20
- Firm location
- Skaneateles Falls, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.