FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
- Recall number
- Z-1692-2015
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
- Status
- Terminated
- Initiated
- 2015-03-21
- Posted
- 2015-05-29
- Terminated
- 2015-11-20
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 5 UPDATE 4-20-2015 to include 10 additional devices
- Distribution
- MN
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K030407"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28