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

FDA device recall Z-1692-2015 · posted 2015-05-29 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CCK

Quantity affected

5 UPDATE 4-20-2015 to include 10 additional devices

Distribution

MN

Date initiated

2015-03-21

Date posted

2015-05-29

Date terminated

2015-11-20

Location

Saint Paul, MN

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