FDA Medical Device Recalls (openFDA)
Cardiac Science Corporation: Powerheart G5 Automatic AED
- Recall number
- Z-1938-2019
- Recalling firm
- Cardiac Science Corporation
- Product
- Powerheart G5 Automatic AED
- Status
- Terminated
- Initiated
- 2019-06-04
- Posted
- not on file
- Terminated
- 2021-11-15
- Reason
- Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
- Root cause
- Process control
- Action
- Cardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at techsupport@cardiacscience.com. Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and provided a list with customer names, contact information (including phone and email addresses) and affected device serial numbers to Cardiac Science. The list can be provided by calling 800.426.0337 or by emailing it to techsupport@cardiacscience.com.
- Quantity
- 5 devices
- Distribution
- US distribution to Georgia, Texas, and Wisconsin.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- ["P160033"]
- Product code
- MKJ
- Firm FEI
- 2112020
- Firm city
- Deerfield
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28