Recall Z-1082-2013
Physio Control, Inc. · initiated February 8, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
Codes / lots: Serial numbers of devices distributed in the US: 33219251, 33220310, 33220344, 33220367, 33220369, 33220376, 33220402, 33220450, 33220461, 33220464, 33220466, 33220470, 33221200, 33221394, 33231481, 33231486, 33231488, 33231492, 33231511, 33231512, 33231521, 33231523, 33231524, 33231527, 33231532, 33231535, 33231536, 33231539, 33231545, 33231546, 33231554, 33231611, 33231614, 33231618, 33231623, 33231625, 33231628, 33231635, 33231636, 33231639, 33231641, 33231685, 33231712, 33231728, 33231733, 33231737, 33231741, 33231745, 33231755, 33231758, 33232813, 33232814, 33232816, 33237363, 33238809, 33239104, 33239111, 33239118, 33239125, 33239127, 33239134, 33239139, 33239154, 33239159, 33239164, 33239184, 33239194, 33239206, 33239243, 33239251, 33239260, 33239261, 33239262, 33239264, 33239265, 33239267, 33240071, 33240074, 33240087, 33240093, 33240102, 33240104, 33240106, 33240109, 33243833, 33243849, 33243931, 33243932, 33246462, 33246464, 33246487, 33246497, 33246540, 33246541, 33246542, 33246543, 33246547, 33246549, 33246553, 33246555, 33247992, 33248321, 33248795, 33249349, 33250900, 33250959, 33251067, 33251163, 33251910, 33251916, 33251930, 33251931, 33252751, 33252759, 33252761…
Reason for recall
LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
FDA-determined cause: Component design/selection
Action taken
The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device. Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.
Details
- Recall number
- Z-1082-2013
- Initiated
- February 8, 2013
- Posted by FDA
- April 10, 2013
- Terminated
- November 5, 2015
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 54,197 units in US and 78,627 units internationally (total 132, 824 units)
- Distribution
- Worldwide Distribution.
- Recalling firm
- Physio Control, Inc., Redmond, WA