Powerheart¿ G5 Automatic AED recall
Powerheart¿ G5 Automatic AED
Why was Powerheart¿ G5 Automatic AED recalled?
Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number G5A 80A; AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).
- Product
- Powerheart¿ G5 Automatic AED
- Recalling firm
- Cardiac Science Corporation
- Quantity
- 5 devices
- Distribution
- US distribution to Georgia, Texas, and Wisconsin.
- Recall date
- July 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)