# FDA recall Z-1563-2020

> **LivaNova USA Inc** · Class II · device recall initiated 2020-02-04.

## Product

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

## Reason for recall

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

## Distribution

U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT.    Canada, and Israel.

## Key facts

- **Recall number:** Z-1563-2020
- **Recalling firm:** LivaNova USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-02-04
- **Report date:** 2020-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2020

## Citation

> AI Analytics. FDA recall Z-1563-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1563-2020. Source: US FDA. Licensed CC0.

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