Recall Z-1199-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The 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 | May 19, 2009 (initiated Mar 30, 2009) |
| Status | Terminated |
| Reason | Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent - Medical Device Recall Letter and Notice dated March 2009 were issued to affected customers. Mailings of the Urgent - Medical Device Recall Letter and Notice were handled by Philips Healthcare representatives in each affected geography. Customers were asked to follow the "Actions to be taken by customer/user" section of the Urgent - Medical Device Recall Notice. In this section, customers were instructed to remove the device from service if possible, while they await the correction of their device. If the customer is unable to remove the device from service, they are asked to ide |
| Quantity | 26,992 |
| Distribution | Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT |
| 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 |