Recall Z-1903-2010
Physio Control, Inc. · initiated May 27, 2010
Product
LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.
Codes / lots: Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000. SERIAL NUMBERS: 30293716, 30293718, 30293720, 30293721, 30353602, 30353606, 30353609, 30353618, 30353623, 30353626, 30353630, 30353656, 30402649, 30402650, 30402651, 30402652, 30405826, 30405827, 30405828, 30405829, 30405830, 30405831, 30405832, 30405833, 30405834, 30405836, 30405837, 30405838, 30405839, 30405841, 30405842, 30405844, 30405845, 30405847, 30405848, 30405849, 30405850, 30405851, 30405852, 30410865, 30410866, 30410867, 30410868, 30410869, 30410870, 30410871, 30410872, 30410873, 30410874, 30410875, 30410876, 30410877, 30410878, 30412193, 30412194, 30412195, 30412328, 30412329, 30412330, 30412331, 30412332, 30412333, 30412334, 30413678, 30413679, 30413680, 30413681, 30413682, 30413720, 30413873, 30413874, 30413875, 30413876, 30413877, 30413878, 30413890, 30413891, 30413892, 30413893, 30413894, 30413895, 30413928, 30413930, 30414186, 30414187, 30414195, 30414197, 30414204, 30415018, 30415019, 30415020, 30415021, 30415022, 30415023, 30415049, 30415050, 30415051, 30415052, 30415053, 30415131, 30415132, 30415133, 30415134, 30415135, 30415136, 30415137, 30415138, 30415139, 30415140…
Reason for recall
A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.
FDA-determined cause: Material/Component Contamination
Action taken
Firm began mailing Urgent Medical Device Correction notifications to affected customers on May 26, 2010 regarding the power supply to the device. All affected power supplies will be updated; this will be accomplished in two phases. Devices at a higher risk will be updated first in phase 1. The remaining lower risk devices will be updated afterward in Phase 2. Customers are advised to keep the defibrillators in service, and to follow recommended daily Operator Checklist steps, while service updates are scheduled. Customers with questions should contact the firm at 800-442-1142 between 6 am and 4 pm Pacific Time, Monday - Friday
Details
- Recall number
- Z-1903-2010
- Initiated
- May 27, 2010
- Posted by FDA
- July 1, 2010
- Terminated
- October 21, 2014
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 43,001 units
- Distribution
- Worldwide distribution. In US, distributed domestically including to gov't accounts; and internationally to the following countries: ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON…
- Recalling firm
- Physio Control, Inc., Redmond, WA