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U.S. Department of Health and Human Services

Class 3 Device Recall NuVasive MD Pulse III Multimodality System

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  Class 3 Device Recall NuVasive MD Pulse III Multimodality System see related information
Date Initiated by Firm July 19, 2022
Date Posted February 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-1052-2023
Recall Event ID 91294
510(K)Number K210574  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product NuVasive MD Pulse III Multimodality System REF 1881500

Pulse Software version 369-BL.US and 369-BLN.US
Code Information Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
Recalling Firm/
Manufacturer		 NuVasive Inc
7475 Lusk Blvd
San Diego CA 92121-5707
For Additional Information Contact Patrick Yrigoyen
858-336-3421
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Between 07/19/2022 to 12/02/2022, affected customers were contacted and verbally informed during a software update that there was an issue related to the inability to remotely connect their system and does not allow physicians who is not physically in the operating room to be able to review live neuromonitoring data remotely and provide analysis to the surgeon in the operating room. The firm is planning on sending an "URGENT: MEDICAL DEVICE RECALL" Letter on 01/13/2023, to officially inform customers that a recall is being conducted due to a remote monitoring issue that may potentially not allow a physician who is not physically in the operating room to be able to review live neuromonitoring data remotely and provide analysis to the surgeon in the operating room. Customer Instructions: -Nuvasive, Inc. will contact a Representative at the hospitals to schedule the software key upgrade. -If the security key has been updated, no further action is necessary. For questions or assistance, contact Sr. Director, Global Quality at 858-336-3421 or email pyrigoyen@nuvasive.com
Quantity in Commerce 7
Distribution U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = NuVasive, Incorporated
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