da Vinci Vision System Cart — Class III medical device recall Z-0146-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-11-13, distributed nationwide. Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the
| Recall number | Z-0146-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-10-21 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, FI, FR, GB, IL, IN, IT, KR, MX, NL, NO, PA, PK, QA, RO, SA, SE, SG, TR, TW |
| Serial numbers | 11K1903D7944, 11K1903D7949, 11K1903D7950, 11K1903D7951, 11K1903D7952, 11K1903D7953, 11K1903D7954, 11L1903D7989, 11L1903D7990, 11L1903D7991, 11L1903D7992, 11L1903D7993, 11L1903D7994, 11L1903D7995, 11L1903D7996, 11L1903D7997, 11L1903D7998, 11L1903D7999, 11L1903D8000, 11L1903D8001, 11L1903D8002, 11L1903D8003, 11L1903D8004, 11L1903D8005, 11L1903D8006 and 475 more |
| Model numbers | 380990, Y1903 |
Product
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended.
Reason for recall
Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.
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-0146-2014. 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.