Surgeon console displays recalled over firmware that can lose visualization

Plain-English summary

The da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, part number 380730-45, is being recalled by Intuitive Surgical, Inc.

The record states the robotic-assisted surgical system has a Viewer Display manufactured with outdated firmware. It states this may result in loss of one display, meaning loss of the 3D surgical field and depth perception with 2D maintained, or loss of both displays, meaning complete visualization loss, without fault. The record states instruments remain active, which could lead to instrument contact with tissue resulting in injury or bleeding, and that the situation may require an alternate surgical modality.

The record lists 47 units under UDI 00886874119747, with serial numbers recorded in the enforcement record. Distribution was nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Intuitive Surgical's instructions.

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 — Surgical robotics

Hazard

• outdated-firmware
• visualization-loss
• surgical-robot
• injury-risk

Affected units

47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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