Z-1518-2024Class II

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

Name: Z-1518-2024 Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Creator: Intuitive Surgical, Inc.
Published: 2024-03-13
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2024-03-13 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 on 2024-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1518-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-13
Posted: 2024-04-11
Recalling firm: Intuitive Surgical, Inc.
Product: Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]
Quantity in commerce: 53
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)