Recall Z-1052-2023 ยท OLO Orthopedic Stereotaxic Instrument
NuVasive Inc
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
| Date | Feb 3, 2023 (initiated Jul 19, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 al |
| Quantity | 7 |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210574 | NuVasive Pulse System Nu Vasive, Incorporated, Jul 29, 2021 |