BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
FDA device recall Z-1089-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 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
- Date initiated
- 2007-06-05
- Date posted
- 2007-07-23
- Date terminated
- 2008-10-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVISOR, MODEL 9200 (K030407) | Bci, Inc. | 2003-08-19 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K010770) | Bci, Inc. | 2001-06-12 |
| VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279) | Bci Intl., Inc. | 1998-09-25 |