FDA Device recall Z-0993-2020
Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 by Cardinal Health 200, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0993-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-28 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
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.
Identifiers
| code_info | All product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0993-2020%22
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