Cardiac Science AED Recall

                    Another AED recall has been announced by the FDA:

1) Powerheart 9300A automated external defibrillator. This fully
automatic model does not require the user to press a shock button in
order for the device to deliver therapy (when appropriate). Brand
name:
Cardiac Science. Product name: Powerheart. Device Operation: Fully
automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome:
No.
Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall
# Z-1243-2010;
2) Powerheart 9300E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in
order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device
Operation:
Semi-automatic. Color: Yellow. Voice Prompt Level: Basic. CPR
Metronome:
No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1244-2010;
3) Powerheart 9300P automated external defibrillator. This
semi-automatic model requires the user to press a shock button in
order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device
Operation:
Semi-automatic w/manual override. Color: Yellow. Voice Prompt Level:
Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display:
Yes. ECG Display: Yes. Recall # Z-1245-2010;
4) Powerheart 9390A automated external defibrillator. This fully
automatic model does not require the user to press a shock button in
order for the device to deliver therapy (when appropriate). Brand
name:
Cardiac Science. Product name: Powerheart. Device Operation: Fully
automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive
voice
prompts provide more detailed instruction on device use, pad placement
and CPR performance, as compared to the basic prompts.) CPR Metronome:
Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1246-2010;
5) Powerheart 9390E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in
order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device
Operation:
Semi-automatic. Color: Yellow. Voice Prompt Level:
Extensive.(Extensive
voice prompts provide more detailed instruction on device use, pad
placement and CPR performance, as compared to the basic prompts.) CPR
Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG
Display: No. Recall # Z-1247-2010;
6) Responder 2023440 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in
order
for the device to deliver defibrillation energy (when appropriate).
Brand name: GE. Product name: Responder. Device Operation:
Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level:
Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display:
Yes. ECG Display: Yes. Recall # Z-1248-2010;
7) Cardiovive 92532 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in
order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Burdick. Product name: Cardiovive. Device Operation:
Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome:
No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1249-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Science Corp., Bothell, WA, by letters on
February 3, 2010.
Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated
recall is ongoing.  
REASON
A component of the AED device may fail during a rescue attempt and the
AED will not be able to deliver therapy.
VOLUME OF PRODUCT IN COMMERCE
12,077 units
DISTRIBUTION
Nationwide

Full details can be found at
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm208729.htm




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