RESONATE X4 CRT-D, Model G447, Sterile.
Reported: November 15, 2017 Initiated: October 4, 2017 #Z-0081-2018
Product Description
RESONATE X4 CRT-D, Model G447, Sterile.
Reason for Recall
The devices have an incorrect firmware configuration.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 11 devices
- Distribution
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
RESONATE X4 CRT-D, Model G447, Sterile.. Recalled by Boston Scientific Corporation. Units affected: 11 devices.
Why was this product recalled? ▼
The devices have an incorrect firmware configuration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0081-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11