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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00023-1
Product Name/Description	CellAED 2.2 Serial Numbers: 11465, 13807, 13840, 12728, 13663, 12997, 9858, 12491, 8783, 3503, 9831, 10627, 10836, 12231, 12339, 12851, 13903, 15333 ARTG 375339 (RRR Manufacturing Pty Ltd - Non-rechargeable public automated external defibrillator)
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	11/01/2024
Responsible Entity	RRR Manufacturing Pty Ltd
Reason/Issue	CellAED 2.2 is designed to flash amber to alert the customer when there is a low battery voltage and flash green when the battery operates within expected range. Analysis of data from devices indicate that the devices may be flashing green instead of flashing amber even though the battery is not within accepted voltage range. This poses a potential risk that if the device is used, it may not activate or deliver therapy when required – this will result in delayed/inadequate therapy in attempting to restore sinus rhythm. Each device is issued with a unique serial number. This recall affects only 18 individual devices as per these serial numbers
Recall Action	Recall
Recall Action Instructions	Customers are to cease use of and quarantine devices with the following serial numbers: 11465, 13807, 13840, 12728, 13663 Affected devices should be returned to RRR Manufacturing immediately. A customer service representative will be in contact to organise a return and replacement. Replacement devices are expected to be provided in first week of February.
Contact Information	1300 859 903 - RRR Manufacturing Pty Ltd