FDA Device recall Z-0146-2014
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000
- FDA Device
- Class III
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class III recall of da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000 by Intuitive Surgical, citing 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 Mai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0146-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-21 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
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.
Identifiers
| code_info | Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. Serial numbers: 11K190…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 11L19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2014%22
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