Z-1052-2023Class III

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

Name: Z-1052-2023 NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Creator: NuVasive Inc
Published: 2022-07-19
License: https://open.fda.gov/license/

NuVasive Inc / initiated 2022-07-19 / Open, Classified / root cause: software

FDA source

NuVasive Inc began a recall of NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US on 2022-07-19. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1052-2023
Classification: Class III
Status: Open, Classified
Initiated: 2022-07-19
Posted: 2023-02-03
Recalling firm: NuVasive Inc
Product: NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: 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 [email protected]
Quantity in commerce: 7
Distribution: U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Product codes and lots: Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1052-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1052-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-03

Product code OLO

K210574Class IINuVasive Pulse SystemNu Vasive, Incorporated / cleared 2021-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)