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UTAS
L K C TECHNOLOGIES, INC. · Model UTAS System Type-47 · UDI-DI 00857901006293
GWE
Prescription
10
510(k) clearances
11
Adverse events
3
Recalls
38
Facilities
Description
4CH/AC, BigShot, UV, CRT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-02 | Natus Medical Incorporated | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do |
| 2007-04-02 | Diopsys, Inc. | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. |
| 2004-09-15 | Diopsys Inc | The firm established no medical device quality system, no established quality plan and no established quality procedures. |
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