Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit b
FDA device recall Z-0229-06 · posted 2005-11-30 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.
- Action taken
- Distirbutors and consignees were notified beginning 09/01/05 via email or phone about Safety Action Bulletin 05-004. Customers were asked to respond to Smiths Medical with a written acknowledgement that they received this Safety Action Bulletin (SAB). The SAB described the issue, actions they should take and instruction on how to have the monitor repaired.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 2
- Distribution
- AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
- Date initiated
- 2005-09-01
- Date posted
- 2005-11-30
- Date terminated
- 2007-06-27
- 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 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K011177) | Bci, Inc. | 2001-05-23 |
| VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279) | Bci Intl., Inc. | 1998-09-25 |