Recall Z-1692-2015— Smiths Medical ASD, Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2015-03-21, terminated 2015-11-20. It names one FDA 510(k) clearance: K030407. Product: Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.. 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..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-21
- Terminated
- 2015-11-20
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.