FDA-Device2023-02-15Class III
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
NuVasive Inc
Hazard
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
Sold states
U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Affected count
7
Manufactured in
7475 Lusk Blvd, San Diego, CA, United States
Products
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2023Don't want to check this manually?
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