NuVasive recalls specific software versions for spinal surgery due to remote monitoring connection issues. Affected units may not connect to remote monitoring during critical procedures.
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.
NuVasive is recalling software versions for their MD Pulse III system used in spinal surgeries. The issue prevents remote monitoring during procedures, which could impact patient safety if critical alerts aren't received.
The software has an incorrect security key that prevents connecting to remote monitoring systems. This means critical alerts and assistance during surgery might not be received if the system fails to communicate with monitoring services.
Surgical teams using NuVasive MD Pulse III systems with specific software versions for spinal, neck, thoracic, and extremity procedures. Patients undergoing these surgeries are at risk if remote monitoring fails.
Check for software versions 369-BL.US and 369-BLN.US on the NuVasive MD Pulse III Multimodality System. The product has a specific part number (1881500) and serial numbers listed in the recall notice.
Verify your software version by checking the device settings or documentation for versions 369-BL.US or 369-BLN.US.
The software has an incorrect security key that prevents connecting to remote monitoring during spinal surgery and other procedures.
Check your software version; if it's 369-BL.US or 369-BLN.US, contact NuVasive for guidance.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1052-2023 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-1052-2023 from NuVasive. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.