Cardiac Science Corporation: Powerheart¿ G5 Automatic AED

Is my product affected?

Powerheart¿ G5 Automatic AED

• UPC 00812394021222

Check against the official notice below — it lists the full affected range.

What happened

Cardiac Science Corporation recalled 5 Powerheart G5 Automatic AED devices due to insufficient documentation from a sub-supplier regarding specific Printed Circuit Boards (PCBs), making it impossible to verify whether the devices meet required specifications. The affected devices were distributed to Georgia, Texas, and Wisconsin and include Model Number G5A 80A units with specific serial numbers ending in 133922, 133927, 133930, 133934, and 133936.

The recall record does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications. Distribution: US distribution to Georgia, Texas, and Wisconsin. Quantity: 5 devices Lot/code info: 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).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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