RESONATE EL ICD DR, Model D433, Sterile.
Reported: November 15, 2017 Initiated: October 4, 2017 #Z-0078-2018
Product Description
RESONATE EL ICD DR, Model D433, Sterile.
Reason for Recall
The devices have an incorrect firmware configuration.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 12 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 EL ICD DR, Model D433, Sterile.. Recalled by Boston Scientific Corporation. Units affected: 12 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-0078-2018.
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