FDA Device recall Z-0081-2018
RESONATE X4 CRT-D, Model G447, Sterile
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of RESONATE X4 CRT-D, Model G447, Sterile by Boston Scientific, citing the devices have an incorrect firmware configuration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0081-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-04 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | MN, OH |
Product
RESONATE X4 CRT-D, Model G447, Sterile.
Reason
The devices have an incorrect firmware configuration.
Identifiers
| code_info | Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.