Smiths Medical, BCI Advisor Vital Signs Monitor, Product… recallZ-1692-2015 · Smiths Medical ASD, Inc. · initiated Mar 21, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] 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 [email protected]. 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.
Recall details
- Recall number
- Z-1692-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 21, 2015
- Posted by the FDA
- May 29, 2015
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 5 UPDATE 4-20-2015 to include 10 additional devices
- Product code
- CCK
- FDA submissions
- K030407
- Distribution
- MN
Product description
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K030407 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BCI WW1100Icu Medical, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 reports
- BCI 920654230AIcu Medical, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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