NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

FDA device recall Z-1052-2023 · posted 2023-02-03 · Open, Classified

Recall details

Recalling firm

NuVasive Inc

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.

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

OLO

Quantity affected

7

Distribution

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

Date initiated

2022-07-19

Date posted

2023-02-03

Location

San Diego, CA

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