Recall archive / FDA device enforcement
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 — FDA record Z-1518-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 13, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 53
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1518-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- Mar 13, 2024
- Center classification date
- Apr 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.