Recall Z-1089-2007 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Smiths Medical PM, Inc.
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
| Date | Jul 23, 2007 (initiated Jun 5, 2007) |
| Status | Terminated |
| Reason | Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on. |
| Root cause | Other |
| Action | Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair. |
| Quantity | 57 |
| Distribution | International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel |
| FDA record | Open on fda.gov |