ClearanceBrief
Recall Z-1118-2025 ยท LLZ System, Image Processing, Radiological

Medicrea International

UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follo

DateFeb 7, 2025 (initiated Dec 3, 2024)
StatusOpen, Classified
ReasonDue to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
Root causeSoftware design
ActionOn 12/03/2024, Medtronic sent an "Urgent Medical Device Correction" notification to physician users of the UNiD HUB informing them of a software anomalies in the UNiD" HUB that may have impacted UNiD rod planning and certain optional surgical parameters (Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification), and may have errors that resulting in incorrect calculations displayed in the UNiD" HUB. Medtronic is also informing users of a Software update that has removed the impacted parameters. The software update was released on 12/03
Quantity1,548 users
DistributionU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Argentina Australia Belgium Brazil Bulgaria Chile Czech Republic Denmark Finland
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K212005UNiD Spine Analyzer
Medicrea International, Inc., Jan 12, 2022