Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibr
FDA device recall Z-2110-2009 · posted 2009-09-18 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- 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
- Action taken
- 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). .
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 445 devices worldwide
- Distribution
- Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.
- Date initiated
- 2009-08-12
- Date posted
- 2009-09-18
- Date terminated
- 2012-08-10
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937) | Physio-Control, Inc. | 2009-03-11 |