FDA Medical Device Recalls (openFDA)
Smiths Medical PM, Inc.: BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
- Recall number
- Z-1089-2007
- Recalling firm
- Smiths Medical PM, Inc.
- Product
- BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
- Status
- Terminated
- Initiated
- 2007-06-05
- Posted
- 2007-07-23
- Terminated
- 2008-10-29
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 57
- Distribution
- International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K010770","K030407","K982279"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 2183502
- Firm city
- Waukesha
- Firm state
- WI
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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