Patient Cart, Part: 380601, a component of the da Vinci SP… recallZ-1518-2024 · Intuitive Surgical, Inc. · initiated Mar 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 3/13/24, Field Safety Notices were mailed and emailed to customers who were asked to do the following: 1) To prevent a pinch injury, please use two people when attempting to move the EGM in an unpowered state. 2) Inform necessary hospital personnel about this issue and affected personnel when the requested actions have been completed. 3) Complete and return the response form via email to [email protected] A firm representative will schedule a site visit to perform the inspection of the Link 2 EGM belts of the affected population of SP systems. If you need further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Firm Customer Service: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or [email protected] - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or [email protected]
Recall details
- Recall number
- Z-1518-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 13, 2024
- Posted by the FDA
- Apr 11, 2024
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 53
- Product code
- NAY
- FDA submissions
- K173906, K182371
- Distribution
- US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea
Product description
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Code information (models, lots, serial numbers)
Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- da Vinci SP 380601Intuitive Surgical, Inc. · System, surgical, computer controlled instrument2 recalls9 deaths286 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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