Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The
FDA device recall Z-0531-05 · posted 2005-02-10 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.
- Action taken
- On 12/22/04 distribution of new units was placed on hold and customers were notified to recommend that they do not use the pace detect function. On 12/27/03 an email was sent to customers of the solution. On 12/29/04 a Technical Worksheet describing how to replace a resistor at R8 was emailed to customers. Between 12/29/04 and 01/03/05 kits containing instructions and new resistors were sent to customers to begin reworking of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 11
- Distribution
- Internationally only.
- Date initiated
- 2005-01-05
- Date posted
- 2005-02-10
- Date terminated
- 2005-11-14
- 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) (K011177) | Bci, Inc. | 2001-05-23 |
| VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279) | Bci Intl., Inc. | 1998-09-25 |