Recall Z-1232-2014— Philips Medical Systems North America Inc.

Name: FDA recall Z-1232-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-06

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems North America Inc., initiated 2014-02-06, terminated 2017-03-23. It names 2 FDA 510(k) clearances: K040904, K020715. Product: Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).. Reason: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency..

Recalling firm: Philips Medical Systems North America Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-06
Terminated: 2017-03-23
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

2 on FDA's record

K040904 — PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068APhilips Medical Systems·cleared 2004-09-16
K020715 — PHILIPS M5066A AND M5068APhilips Medical Systems·cleared 2002-11-08

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 Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).

Reason for recall

Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.

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