Device product
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Z-1052-2023
Product summary
- Firm
- NuVasive Inc
- Event
- Event 91294
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 7
- Official record key
device-enforcement:Z-1052-2023
Official wording
Reason: 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.
Code information: Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
Distribution pattern: U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Derived failure modes
-
Unknown
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.