da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply — Class II medical device recall Z-3254-2018
Terminated recall by Intuitive Surgical, Inc., reported 2018-10-03, distributed nationwide. Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts
| Recall number | Z-3254-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-09-26 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2023-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, KW, LU, MX, NL, NO, NZ, RO, RU, SA, SE, SG, TR, TW, VE |
| Quantity | 1,014 currently |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00886874110683, 00886874110690, 00886874110713, 00886874110744 |
Product
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
Reason for recall
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3254-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.