Recall Z-1123-2017— Physio-Control, Inc.
Class I · Terminated
Class I FDA medical device recall by Physio-Control, Inc., initiated 2017-01-12, terminated 2017-09-01. It names one FDA 510(k) clearance: K142430. Product: LIFEPAK 15 Monitor, Automated External Defibrillator (AED), 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: The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA)..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-01-12
- Terminated
- 2017-09-01
- 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, Automated External Defibrillator (AED), 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 for recall
The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).
Data sourced from openFDA. This site is unofficial and independent of the FDA.