Recall Z-2388-2008
Physio Control, Inc. · initiated June 18, 2008
Product
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.
Codes / lots: 34770807, 34777474, 34248216, 34254636, 34254671, 34254685, 31187022, 30587142, 30587166, 30587186, 31125454, 34643248, 34656788, 34656804, 34659617, 34659623, 34660690, 34785299, 32656285, 32460934, 32283224, 33181888, 34840335, 34842373, 32411681, 31547316, 30762432, 30762952, 33820870, 33829090, 33829105, 33884866, 33884867, 33884871, 33884872, 33884879, 33884912, 34785326, 30512983, 30417182, 30891999, 33648604, 33648620, 33649857, 33675449, 33675464, 33675472, 33675482, 33675485, 33680844, 35072670, 32514984, 30705232, 30710503, 30733371, 30733375, 30733379, 30733381, 30744762, 30751005, 30751014, 30761083, 30892001, 31339179, 32191084, 33035397, 33050905, 34107307, 31785232, 31785241, 31800890, 32920897, 32920899, 32920901, 32972820, 31891378, 34713400, 34713413, 34713416, 34718778, 32910909, 33808032, 31783372, 32351425, 33950589, 33239552, 35027042, 35065651, 35055271, 35057695, 35057696, 35057704, 35072687, 35457568, 35457586, 35474783, 35514411, 35514436, 35529896, 35529900, 35529904, 35529908, 35529911, 35529912, 35529915, 35529919, 35529924, 35529926, 35638460, 35642597, 34477226, 34817338, 34820819, 34820825, 32703354, 32704306, 34549521, 34549536, 34549550…
Reason for recall
Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.
Details
- Recall number
- Z-2388-2008
- Initiated
- June 18, 2008
- Posted by FDA
- September 21, 2008
- Terminated
- September 4, 2013
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 45,209 devices
- Distribution
- There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.
- Recalling firm
- Physio Control, Inc., Redmond, WA