Device Recall BCI Advisor Vital Signs Monitor 의 리콜

Recall

70793

Class 2

Z-1692-2015

2015-03-21

2015-05-29

Terminated

United States

2015-11-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134714

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.

Consignee was sent on 3/20/2015 a Smiths Medical "Urgent Medical Device Recall" letter dated 13 March 2015. The letter was addressed to Supplier Quality. The letter described the issue and the product affected by the recall. Requested consignees to quarantine the affected product and to complete and return the Confirmation Form by Fax to 1-800-237-8033 or by email to recall.response@smiths-medical.com within 10 days of receipt of this letter. Customers shall report any issues with these products to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcompaints@smiths-medical.com. For questions they can contact Smiths Medical's Customer Service Department at 1-800-258-5361. UPDATE 4-20-2015 Smiths Medical sent an Urgent Medical Device Recall letter via email to the one consignee on April 10, 2015. The letter identified the additional monitors and requested that those devices be quarantined, return the attached confirmation form, and a customer service representative will contact the consignee to arrange for exchange of the affected Advisor monitors for credit or replacement.