device recall
saveIntuitive Surgical, Inc. device recall (Cls II)
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da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 — Reason: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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. — Status: Ongoing
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same company · ±60 days · 6
- device 510kIntuitive Surgical, Inc. — IRISeg (510k cleared)Dec 16, 2025
- device 510kIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)Dec 15, 2025
- device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 15, 2025
- device 510kIntuitive Surgical, Inc. — da Vinci Surgical System (IS5000) (510k cleared)Jan 16, 2026
- device 510kIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (510k cleared)Jan 16, 2026
- device recallIntuitive Surgical, Inc. device recall (Cls II)Dec 9, 2025
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