| | Class 2 Device Recall Da Vinci 5 |  |
| Date Initiated by Firm | August 21, 2024 |
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| Date Posted | December 19, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0964-2026 |
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| Recall Event ID |
98048 |
| 510(K)Number | K232610 |
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| Product Classification |
System, surgical, computer controlled instrument - Product Code NAY
|
| Product | da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
|
| For Additional Information Contact | Shahbaz Khan
408-523-2443 |
|---|
Manufacturer Reason
for Recall | 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 |
|---|
FDA Determined
Cause 2 | Device Design |
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| Action | On 8/21/2024, correction notices were sent to customers who were informed of the following:
1) Share this notification with all personnel at your site who perform and support da Vinci procedures.
2) Inform affected personnel when the correction has been completed.
3) Complete and return the acknowledgement form via email to Recalls@intusurg.com
4) Retain a copy of this letter and the acknowledgement form for your files.
5) Firm is actively working on making updated motor module assemblies available. Once available, an Intuitive representative will schedule a visit to replace the affected motor module sub-assembly.
If you need further information or support concerning this notification, please contact the firm's Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com |
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| Quantity in Commerce | 144 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NAY
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