Reported Feb 22, 2017 · Terminated
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended…
Physio-Control, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physio-Control, Inc. · 11811 Willows Rd NE · Redmond, WA · 98052-2003
Is this the product you have?
- 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.
- Lot codes and dates
- SERIAL NUMBERS
338 of 338 codes
427388724455410242701550427025394273081542800549428039864286210942884428429446094298932743022460430406924304879143066974431168384311699443119477431329544313320343133221431339064315430843154457431566954316142543163930431640764316415843166133432060344321001943219622432262914323003243232487432329044324738943251050432535064325391643254032432589014329329043321556433881324338813743388541434055424340794743409346434295084346537243472036434725914348082443489606434928834357602143616526
- SERIAL NUMBERS
- Amount recalled
- 338 units total (US =139 units; International = 199 units)
Where it was sold
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Physio-Control, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.