Recall Z-1619-2008 ยท DQA Oximeter
Smiths Medical PM, Inc.
BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.
| Date | Aug 15, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Vendor change control |
| Action | 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. |
| Quantity | 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, India, Germany, Guatemala, Pakistan, Chile, Colombia, Brazil, Saudi Arabia, Morocco, Kuwait, Trin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020350 | BCI 3180 PULSE OXIMETER Bci, Inc., Apr 30, 2002 |