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Recall Observatory FDA recall evidence

Device product

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

Z-1692-2015

March 21, 2015

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 70793
Status
Terminated
Classification
Class II
Quantity
5 UPDATE 4-20-2015 to include 10 additional devices
Official record key
device-enforcement:Z-1692-2015

Official wording

Reason: The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

Code information: Serial Numbers: 4059587 through 4059591 UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960

Distribution pattern: MN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.