FDAFDA · Food and drugs·Recall number Z-0077-2018
RESONATE EL ICD VR, Model D432, 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 224020, 224209, 224322, 224366, and 224506
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.