Food, drugs, devices › Intuitive Surgical, Inc.
Device recall: da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lam
FDA enforcement event 66570 is a device recall by Intuitive Surgical, Inc. of Sunnyvale, CA, initiated 21 Oct 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 4 Sep 2014. Initiation: voluntary: firm initiated. Intuitive Surgical, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Intuitive Surgical, Inc., Sunnyvale, CA.
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."
Distribution
"Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0146-2014 | 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… | Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units | Class III | Terminated | 13 Nov 2013 |
Context
Other enforcement events for Intuitive Surgical, Inc.
All 105 events for Intuitive Surgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.