Intuitive Surgical, Inc.: da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Read the official notice at FDA (device) →
Get alerts for Intuitive Surgical
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Intuitive Surgical, Inc.
- Product
- da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
- Reason / hazard
- Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.
- Recall initiated
- 2025-12-30
- Code info
- UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761
- Product quantity
- 47
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Sunnyvale
- State
- CA
- Country
- United States
- Event id
- 98205
Free daily digest + "My products" watchlist