Class 2 Device Recall Genius 2 and Genius 3 Tympanic Thermometers.

• Date Initiated by Firm: October 28, 2019
• Create Date: February 04, 2020
• Recall Status: Terminated on May 17, 2022
• Recall Number: Z-0991-2020
• Recall Event ID: 84202
• 510(K)Number: K060649
• Product Classification: Thermometer, electronic, clinical - Product Code FLL
• Product: Genius 3 Tympanic Thermometer- electric thermometer; Item Code: 303013
• Code Information: All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 15 Hampshire St Bldg 5; Mansfield MA 02048-1113
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Cardinal Health issued Correction Notice and Acknowledgement Form via overnight on October 28, 2019 to the direct consignees. The Medical Device Correction Notice provides instructions to our direct consignees to notify any customers who they may have further distributed affected product as to the market action. Letter states reason for recall, health risk and action to take: Customers are instructed that if they have access to a Genius Checker/Calibrator to calibrate all affected Genius thermometers. Following calibration, customers are to contact Cardinal Health Service & Repair to schedule and arrange for the software update on their Genius Checker/Calibrator. Once the updated Genius Checker/Calibrator has been returned to your facility, recalibrate all thermometers. If a customer does not have access to a Genius Checker/Calibrator, they are instructed to contact Cardinal Health Service & Repair to schedule and arrange for their thermometer(s) to be sent to a service center. Contact Cardinal Health Service & Repair to schedule and arrange for your thermometer(s) to be sent to one of our service centers. Monday  Friday between 8:00am - 8:00pm EST Service and Repair Line  877-227-3462, Option 1
• Quantity in Commerce: 7425 US; OUS 214278
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FLL and Original Applicant = TYCO HEALTHCARE GROUP, LP