VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reported: August 8, 2018 Initiated: January 24, 2018 #Z-2572-2018
Product Description
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reason for Recall
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Details
- Recalling Firm
- LivaNova USA Inc
- Units Affected
- 243 devices total
- Distribution
- Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2. Recalled by LivaNova USA Inc. Units affected: 243 devices total.
Why was this product recalled? ▼
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2572-2018.
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