Z-1563-2020 Class II Ongoing
FDA device recall Z-1563-2020 was initiated by LivaNova USA Inc on February 4, 2020 and is designated Class II. 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 i… The recall status is ongoing. Affected quantity: 2683.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 4, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2683
Product Description
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 Pattern
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.
Code Information
Model 3000 version 1.6