VNS Therapy¿ AspireSR¿ Generator
Reported: November 25, 2020 Initiated: September 28, 2020 #Z-0462-2021
Product Description
VNS Therapy¿ AspireSR¿ Generator
Reason for Recall
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
Details
- Recalling Firm
- LivaNova USA Inc
- Units Affected
- 134 generators
- Distribution
- U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
VNS Therapy¿ AspireSR¿ Generator. Recalled by LivaNova USA Inc. Units affected: 134 generators.
Why was this product recalled? ▼
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0462-2021.
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