Recall Z-1144-2017— Physio-Control, Inc.
Class II · Terminated
Class II FDA medical device recall by Physio-Control, Inc., initiated 2017-01-16, terminated 2018-09-11. It names one FDA 510(k) clearance: K142430. Product: LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. 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.. Reason: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-16
- Terminated
- 2018-09-11
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. 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.
Reason for recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.