Z-0078-2018 Class II Terminated
FDA device recall Z-0078-2018 was initiated by Boston Scientific Corporation on October 4, 2017 and is designated Class II. Reason for recall: The devices have an incorrect firmware configuration. The recall status is terminated (terminated October 15, 2019). Affected quantity: 12 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 4, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product Description
RESONATE EL ICD DR, Model D433, Sterile.
Reason for Recall
The devices have an incorrect firmware configuration.
Distribution Pattern
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Code Information
Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.