Recall Z-1240-2007 ยท DQA Oximeter
Smiths Medical PM, Inc.
BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc
| Date | Sep 21, 2007 (initiated Jul 18, 2007) |
| Status | Terminated |
| Reason | Phantom pacer spikes caused by a damaged resistor. |
| Root cause | Other |
| Action | 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 provi |
| Quantity | 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, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR Bci Intl., Inc., Aug 20, 1998 |