FDAFDA · Food and drugs·Recall number Z-0081-2018
RESONATE X4 CRT-D, Model G447, Sterile.
Published November 15, 2017 · Recall initiated: October 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices have an incorrect firmware configuration.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
- Lot
- Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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