Reported Nov 13, 2013 · Terminated
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator +…
Intuitive Surgical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- 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.
- Lot codes and dates
- Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing
- Serial numbers(PN 950093-05) Replacement lamp module with coated housing
312 of 312 codes
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
- Serial numbers
526 of 526 codes
1HJD94111HJD94121HJD94151HJD94211HJD94221HJD94241HJD94651HJD94661HJD94671HJD94691HJD94701HJD94721HJD94731HJD94741HJD94751HJD94761HJD94771HJD94781HJD94831HJD94981KJD15541KJD15551KJD15561KJD15571KJD15581KJD15591KJD15601KJD15611KJD15621KJD15631KJD15641KJD15651KJD15661KJD15791KJD15801KJD15811KJD15821KJD15831KJD15841KJD15861KJD15881KJD15891KJD15901KJD15911KJD15921KJD15931KJD15941KJD15951KJD15961KJD15971KJD15991KJD16001KJD16011KJD16021KJD16031KJD16041KJD16051KJD16061KJD16071KJD1609
- Amount recalled
- Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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