FDA Medical devices recall ·
da Vinci 5, Surgeon Console Column Motor Connector recall
- Recall number
- Z-0964-2026
- Date
- (initiated August 21, 2024)
- Company / brand
- Intuitive Surgical, Inc.
1266 Kifer Rd, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 144
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Why was it recalled?
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00886874119747. Serial Numbers: 10476314, 10485693, 10496049, 10497992, 10503432, 10503433, 10507302, 10509551, 10511044, 10511047, 10516467, 10518960, 10518961, 10522438, 10522439, 10522441, 10523771, 10523773, 10523775, 10523776, 10523777, 10523778, 10523779, 10523780, 10523781, 10529917, 10529918, 10529919, 10529920, 10529922, 10534426, 10534428, 10534429, 10534430, 10534752, 10534753, 10534754, 10534755, 10534757, 10543027, 10543028, 10543048, 10543051, 10544670, 10544676, 10544677, 10544678, 10547713, 10547717, 10547724, 10547728, 10551553, 10551554, 10552616, 10552618, 10552620, 10552621, 10556681, 10556682, 10558195, 10558197, 10558198, 10558202, 10560603, 10560604, 10560607, 10562584, 10562585, 10562586, 10562588, 10565609, 10565610, 10565614, 10567141, 10567143, 10567145, 10569365, 10569367, 10569368, 10569369, 10570704, 10570705, 10570706, 10570707, 10573677, 10573678, 10573679, 10573680, 10573681, 10573682, 10573683, 10573684, 10573685, 10573686, 10576019, 10576021, 10576022, 10576023, 10576024, 10576025, 10576026, 10576027, 10576028, 10579442, 10579446, 10579453, 10579455, 10579456, 10579457, 10579461, 10579466, 10582427, 10582428, 10582429, 10591177, 10591179, 10591180, 10591184, 10591197, 10594614, 10594615, 10594616, 10594617, 10594618, 10594619, 10597107, 10597108, 10597109, 10597110, 10599042, 10599044, 10599045, 10599048, 10600750, 10600753, 10603334, 10603335, 10603343, 10603344, 10603345, 10603367, 10605468, 10606129, 10606133
Distribution
US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.
States: Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Minnesota North Carolina North Dakota New Hampshire New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Virginia Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0964-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.