[pending] da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Pending LLM rewrite. Source: FDA_DEVICE Z-1355-2026.
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
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.
The recalled product
- Product
- da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: 00886874119747
- Serial: SQ0326
- SQ0336
- SQ0341
- SQ0345
- SQ0346
- SQ0356
- SQ0367
- SQ0368
- SQ0375
- SQ0377
- SQ0379
- SQ0380
- SQ0386
- SQ0387
- SQ0389
- SQ0394
- SQ0395
- SQ0398
- SQ0401
Distribution
Distributed nationwide across the United States.
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