Recall Z-0011-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
| Date | Oct 4, 2012 (initiated Sep 11, 2012) |
| Status | Terminated |
| Reason | HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or the |
| Quantity | 2500 units |
| Distribution | Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems, Jul 3, 2002 |