Recall Z-0862-2019
Physio-Control Inc · initiated February 1, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Codes / lots: Serial Numbers: 38344771 38523396 39370585 39747192 40266966 40284286 40284289 40284297 40758461 40767555 40918431 40991313 40991452 40991700 40991743 40991746 40991996 40995181 40995294 40995323 40995420 40995421 40995508 40995550 40995583 40995613 40995621 40995656 41216405 41216406 41216566 41216581 41216600 41216608 41216617 41216618 41216631 41216632 41216636 41216650 41216655 41216660 41216665 41216668 41216680 41216682 41216736 41216743 41216767 41216795 41216797 41216806 41216822 41216828 41216849 41216851 41216854 41216917 41216925 41216955 41216974 41216980 41217013 41217080 41217083 41217104 41217122 41217123 41217131 41217179 41217214 41217221 41217224 41217225 41217233 41217666 41217667 41217677 41217698 41217715 41217722 41217783 41217785 41217791 41217800 41217802 41217834 41217893 41217894 41217929 41218236 41218625 41218627 41218648 41218684 41218810 41218812 41218821 41218846 41218885 41218891 41218909 41218932 41218935 41218938 41218948 41218949 41218951 41219009 41219014 41220729 41220733 41220743 41220763 41220764 41220773 41220794 41220804 41220845 41220854 41220857 41220861 41220862 41220875 41220877 41220885 41220891 41220894 41220941 41220944 41220998…
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-0862-2019
- Initiated
- February 1, 2019
- Posted by FDA
- February 26, 2019
- Terminated
- April 18, 2024
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 13,005 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Physio-Control Inc, Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0863-2019 Class I | LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15…Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was… | 02/01/2019Terminated |