BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) recallZ-1089-2007 · Smiths Medical PM, Inc. · initiated Jun 5, 2007
Terminated All recalls posted in July 2007
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 PM, 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
Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.
FDA root cause category: Other
What the company is doing
Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.
Recall details
- Recall number
- Z-1089-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 5, 2007
- Posted by the FDA
- Jul 23, 2007
- Recalling firm
- Smiths Medical PM, Inc.
- Quantity
- 57
- Product code
- MWI
- FDA submissions
- K010770, K030407, K982279
- Distribution
- International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
Product description
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
Code information (models, lots, serial numbers)
Serial Number AM07030098 AM07030097 AM07030100 AM07030099 AM07030018 AM07020155 AM07020154 AM07020152 AM07020153 AM07030010 AM07030005 AM07030013 AM07030014 AM07030015 AM07030012 AM07030006 AM07030008 AM07030011 AM07030016 AM07030017 AM07030004 AM07030009 AM07030007 AM07030000 AM07030001 AM07030101 AM07030103 AM07030019 AM07020159 AM07020164 AM07020163 AM07020161 AM07020165 AM07020166 AM07020157 AM07020162 AM07020158 AM07020160 AM07020049 AM07020047 AM07020039 AM07020048 AM07020050 AM07020064 AM07030002 AM07030003 AM07030148 AM07030114 AM07020179 AM07020168 AM07020167 AM07030112 AM07020173 AM07020172 AM07020126 AM07030109 AM07020169
Other devices under the same FDA submission
2 devices cleared under K010770, K030407, K982279 — 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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