Recall Z-2110-2009 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Physio Control, Inc.
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allow
| Date | Sep 18, 2009 (initiated Aug 12, 2009) |
| Status | Terminated |
| Reason | Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display |
| Root cause | Software design |
| Action | The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time). . |
| Quantity | 445 devices worldwide |
| Distribution | Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc., Mar 11, 2009 |