| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00588-1 |
| Product Name/Description |
Philips HeartStart XL+ Defibrillator/Monitor
Units Affected: XL+ units with a serial number within the following ranges:
USO1100100 to USD1101095
US11201096 to USD1203968
US11303969 to USD1309471
US11409472 to US61414022
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The following XL+ software and hardware issues have been identified:
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 delay of therapy or pacing interruption.
The XL+ may fail to generate verbal prompts in AED mode.
Hardware:
The XL+ may have been manufactured with a speaker that 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 |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software and hardware upgrades. In the interim, users can continue to use XL+ prior to receiving the software and hardware upgrades; however they should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits any of these issues.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |