Genius 2 & 3 Tympanic Thermometer (2019-10-25)
- Starting date:
- October 25, 2019
- Posting date:
- November 22, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71666
Last updated: 2019-11-22
Affected Products
- Genius 2 Tympanic Thermometer
- Genius 3 Tympanic Thermometer
Reason
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (0.2°C for Genius 2 and 0.3°C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2°C for Genius 2 or +0.3°C for Genius 3.
Affected products
-
Genius 2 Tympanic Thermometer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
303000
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. Genius 3 Tympanic Thermometer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
303013
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES