NuVasive MD Pulse III Multimodality System recall
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Why was NuVasive MD Pulse III Multimodality System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
- Product
- NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
- Recalling firm
- NuVasive Inc
- Quantity
- 7
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
- Recall date
- February 15, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)