Phillips/Laerdal AED Recall

PRODUCT
1) Heartstart FR2+ automated external defibrillator Models M3860A and
M3840A are equipped with an ECG Module. M3860A is under the Philips
label and M3840A is under the Laerdal label. 4 model (catalog) numbers
are affected: M3860A, M3861A, M3840A, and M3841A. Specifics for each
code: M3860A: Philips Heartstart FR2+ Defibrillator with ECG Module
(various languages) M3861A: Philips Heartstart FR2+ Defibrillator Text
Display, No ECG Module (various languages). M3840A: Laerdal Branded
Heartstart FR2+ Defibrillator with ECG Module (various languages).
M3841A: Laerdal Branded Heartstart FR2+ Defibrillator Text Display, No
ECG Module (various languages). Recall # Z-0063-2010;
2) Heartstart FR2+ automated external defibrillator models M3861A and
M3841A are NOT equipped with the ECG Module. Model M3861A is under the
Philips label and M3841A is under the Laerdal label. Recall #
Z-0062-2010
REASON
A potential exists for a component failure, which, if it occurs, could
result in the inability to deliver therapy.
VOLUME OF PRODUCT IN COMMERCE
5808 units
DISTRIBUTION
Nationwide, Canada, Australia, Austria, Bulgaria, China, Finland,
France, Germany, Gibraltar, Great Britain, Hong Kong, India,
Indonesia,
Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands,
Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden,
Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates



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