FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
- Recall number
- Z-0992-2020
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
- Status
- Terminated
- Initiated
- 2019-10-28
- Posted
- not on file
- Terminated
- 2022-05-17
- 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 ( 0.2C 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
- 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
- 3619 OUS
- 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
- Lot, serial or model codes
- All product manufactured after October 1, 2016; Serial Numbers greater than or equal 16597907
- 510(k) numbers
- ["K060649"]
- PMA numbers
- not on file
- Product code
- FLL
- Firm FEI
- 3014524790
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28