Z-0991-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- October 28, 2019
- Termination Date
- May 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7425 US; OUS 214278
Product Description
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe Hong Kong Iran, Islamic Republic Of Ireland Israel Italy Kuwait Liechtenstein Luxembourg Martinique Mayotte Mexico Netherlands New Caledonia New Zealand Norway Panama Philippines Poland Portugal Puerto Rico Qatar Reunion Romania San Marino Saudi Arabia Singapore Slovakia Slovenia South Africa South Korea Spain Swaziland Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
Code Information
All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101