Z-1692-2015 Class II Terminated
FDA device recall Z-1692-2015 was initiated by Smiths Medical ASD, Inc. on Mar 21, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Nov 20, 2015). Affected quantity: 5 UPDATE 4-20-2015 to include 10 additional devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 10, 2015
- Initiation Date
- Mar 21, 2015
- Termination Date
- Nov 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 UPDATE 4-20-2015 to include 10 additional devices
Product Description
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Reason for Recall
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.
Distribution Pattern
MN
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1692-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026