BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient mo
FDA device recall Z-1619-2008 · posted 2008-08-15 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to
- Action taken
- Consignees were contacted by an URGENT: Product Safety Information Voluntary Recall Notification letter dated March 11, 2008 with attached Safety Action Bulletin 08-SAB01 dated February 27, 2008 and email between March 7 and March 13, 2008. The consignees will need to return the device to be evaluated in the Smiths Medical PM, Inc.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 900
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL, AZ, OH, CA, MS, UT and Countries: Argentina, Bangladesh, Iran, Thailand, Mexico
- Date initiated
- 2008-02-27
- Date posted
- 2008-08-15
- Date terminated
- 2011-12-17
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BCI 3180 PULSE OXIMETER (K020350) | Bci, Inc. | 2002-04-30 |