Recall Z-0642-2013— Philips Medical Systems North America Co. Phillips

Name: FDA recall Z-0642-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-26

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems North America Co. Phillips, initiated 2012-07-26, terminated 2020-09-21. It names one FDA 510(k) clearance: K050004. Product: Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.. Reason: Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o.

Recalling firm: Philips Medical Systems North America Co. Phillips
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Terminated: 2020-09-21
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304Philips Medical Systems·cleared 2005-02-25

K-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

Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

Reason for recall

Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o

Data sourced from openFDA. This site is unofficial and independent of the FDA.