LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardi
FDA device recall Z-0862-2019 · posted 2019-02-26 · Terminated
Recall details
- Recalling firm
- Physio-Control Inc
- Reason for recall
- Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
- Action taken
- Stryker sent an Urgent Medical Device Safety Notice & Correction Action Required letter dated February 1, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers. Review the attached impacted device list. Go to www.strykeremergencycare.com/fa281response to provide Stryker verification of the status of the devices listed. Upon confirmation of your device status, a member of our field service personnel will contact you to arrange for the correction of your device. The devices subject to this field action are planned to be serviced by December 31, 2019. If you have questions regarding this matter contact Customer Support team by calling 1 800 442 1142 and selecting option 7.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 13,005 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2019-02-01
- Date posted
- 2019-02-26
- Date terminated
- 2024-04-18
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 monitor/defibrillator (K142430) | Physio-Control, Inc. | 2014-12-19 |