NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Reported: February 15, 2023 Initiated: July 19, 2022 #Z-1052-2023
Product Description
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Reason for Recall
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.
Details
- Recalling Firm
- NuVasive Inc
- Units Affected
- 7
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US. Recalled by NuVasive Inc. Units affected: 7.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Low. Recall number: Z-1052-2023.
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