BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including
FDA device recall Z-1240-2007 · posted 2007-09-21 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- Phantom pacer spikes caused by a damaged resistor.
- Action taken
- Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 178
- Distribution
- World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Gr
- Date initiated
- 2007-07-18
- Date posted
- 2007-09-21
- Date terminated
- 2008-10-31
- 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 |
|---|---|---|
| AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (K981939) | Bci Intl., Inc. | 1998-08-20 |