da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000
Medical device recall Z-0146-2014. Published in FDA’s Enforcement Report on Nov 13, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. Serial numbers: 11K1903D7944 11K1903D7949 11K1903D7950 11K1903D7951 11K1903D7952 11K1903D7953 11K1903D7954 11L1903D7989 11L1903D7990 11L1903D7991…
Every code shown here, 1,995 characters
Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. 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 11L1903D8007 11L1903D8008 11L1903D8009 11L1903D8010 11L1903D8011 11L1903D8012 11L1903D8013 11L1903D8014 11L1903D8015 11L1903D8016 11L1903D8017 11L1903D8018 11L1903D8019 11L1903D8020 11L1903D8021 11L1903D8022 11L1903D8023 11L1903D8024 11L1903D8025 11L1903D8026 11L1903D8027 11L1903D8028 11L1903D8029 11L1903D8030 11L1903D8031 11L1903D8032 11L1903D8033 11L1903D8034 11L1903D8035 11L1903D8036 11L1903D8037 11L1903D8038 11L1903D8039 11L1903D8040 11L1903D8041 11L1903D8042 11L1903D8043 11L1903D8044 11L1903D8045 11L1903D8046 11L1903D8047 11L1903D8048 11L1903D8049 11L1903D8050 11L1903D8051 11L1903D8052 11M1903D8078 11M1903D8079 11M1903D8080 11M1903D8081 11M1903D8082 11M1903D8083 11M1903D8084 11M1903D8085 11M1903D8086 11M1903D8087 11M1903D8088 11M1903D8089 11M1903D8090 11M1903D8091 11M1903D8092 11M1903D8093 11M1903D8094 11M1903D8095 11M1903D8096 11M1903D8097 11M1903D8098 11M1903D8099 11M1903D8100 11M1903D8101 11M1903D8102 11M1903D8103 11M1903D8104 11M1903D8105 11M1903D8106 11M1903D8107 11M1903D8108 11M1903D8109 11M1903D8127 11M1903D8128 11M1903D8129 11M1903D8130 11M1903D8131 11M1903D8132 11M1903D8133 11M1903D8134 11M1903D8135 11M1903D8136 11M1903D8137 11M1903D8138 11M1903D8139 11M1903D8140 11M1903D8141 11M1903D8142 11M1903D8143 11M1903D8144 11M1903D8145 11M1903D8146 11M1903D8147 11M1903D8148 11M1903D8149 11M1903D8150 11M1903D8151 11M1903D8152 11M1903D8153 11M1903D8154 11M1903D8155 11M1903D8156 11M1903D8157 11M1903D8158 12A1903D8292 12A1903D8293 12A1903D8294 12A1903D8295 12A1903D8296 12A1903D8297 12A1903D8298 12A1903D8299 12A1903D8300 12A1903D8301…
FDA’s list runs to 8,970 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, South Korea, Sweden, Switzerland, Taiwan, and Turkey.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 21, 2013.
- FDA classified it on Nov 4, 2013.
- FDA’s Enforcement Report published it on Nov 13, 2013.
- FDA terminated it on Sep 4, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Intuitive Surgical, Inc., of Sunnyvale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,970 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.