Device product
48" Lead Wires, Replacement Part Number: 1067724-4
Z-1619-2024
Product summary
- Firm
- EBI, LLC
- Event
- Event 94291
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 594 units (2 lead wires assembly)
- Official record key
device-enforcement:Z-1619-2024
Official wording
Reason: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Code information: UDI-DI: 00812301020324 All devices distributed since May 1, 2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment