[pending] Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software
Pending LLM rewrite. Source: FDA_DEVICE Z-2310-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
The recalled product
- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integ
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 49 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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