Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18773 |
| Brand Name: | Philips HeartStart XL+ Defibrillator |
| Model: | 861290 |
| Affected: | Serial number ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022 |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems |
| Issue: | Philips has identifed the following XL+ software and hardware issues: Software: * The XL+ may fail to complete the power on sequence and continuously reboot. * The XL+ may either fail to power up or may shut down unexpectedly. * The XL+ may have a software version that did not reset a fail-safe monitoring component which could cause a delay of therapy or pacing interruption. * The XL+ may fail to generate verbal prompts in AED mode. Hardware: * The speaker may fail. * The battery may not seat properly causing the XL+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. * The XL+ exceeds the allowable radiated emissions level for Class B CISPR11. * The XL+ ECG signal from leads could be lost and unrecoverable. * The XL+ SpO2 signal may lose communication and cause the device to reboot. * The XL+ battery detection system may be disrupted and cause a false low battery alarm. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/7/2015 |
