—#177648

Product

Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062

FDA product code: FLL — Continuous Measurement Thermometer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060649
Affected lot / code info: All product manufactured after October 1, 2016; Serial Numbers greater than or equal 16597907

Why it was recalled

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 ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

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

Timeline

Recall initiated: 2019-10-28
Terminated: 2022-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.