FDA Device recall Z-0862-2019
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response sy…
- FDA Device
- Class I
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class I recall of LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response sy… by Physio Control, citing 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 L….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0862-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-02-01 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Physio Control |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Serial Numbers: 38344771 38523396 39370585 39747192 40266966 40284286 40284289 40284297 40758461 40767555 40…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 412 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0862-2019%22
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