FDA Device recall Z-1518-2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
- FDA Device
- Class II
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class II recall of Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 by Intuitive Surgical, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-13 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intuitive Surgical |
| Distribution | AL, CA, CO, FL, KS, KY, MD, MS, NC, NH, NJ, NY, OH, SC, SD, TN, TX, VA, WA, WI, WV |
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.
Identifiers
| code_info | Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP02…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2024%22
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