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Recall Observatory FDA recall evidence

Device product

Powerheart¿ G5 Automatic AED

Z-1938-2019

June 04, 2019

Class II

Product summary

Firm
Cardiac Science Corporation
Event
Event 83103
Status
Terminated
Classification
Class II
Quantity
5 devices
Official record key
device-enforcement:Z-1938-2019

Official wording

Reason: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.

Code information: 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).

Distribution pattern: US distribution to Georgia, Texas, and Wisconsin.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.