The US Food and Drug Administration (FDA) issued a Class II recall related to Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440 manufactured by Cardiac Science Corporation (CSC). The AEDs may enter into a "Service Required" state due to two errors, "0x48" and "0x99".
According to the CSC, the status indicator on the AED will turn red when the errors occur, which means immediate check-up is required.
CSC reminds owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance procedures as specified in operation and maintenance guides provided with every AED. If, at any time, the status indicator turns red, the user must NOT use the device and should contact the local responsible person for service as soon as possible.
According to the local supplier, Pacific Medical Systems, the affected devices have been distributed in Hong Kong.
Pacific Medical Systems supplemented that all affected users will be informed accordingly.
For details, please refer to the following link:
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm275510.htm
If you are in possession of the affected product, please contact your supplier or Pacific Medical Systems for necessary actions.