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Recall Observatory FDA recall evidence

Device product

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

Z-2096-2021

May 17, 2021

Class II

Product summary

Firm
Mediana Co., Ltd.
Event
Event 88166
Status
Terminated
Classification
Class II
Quantity
618
Official record key
device-enforcement:Z-2096-2021

Official wording

Reason: In some cases the equipment fails to power up and/or key or button unresponsive or not working.

Code information: Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Distribution pattern: US Distribution to: Wisconsin only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In some cases the equipment fails to power up and/or key or button unresponsive or not working.