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Da vinci surgical systems

Official notice

9 Mar 2023

Last checked

9 Mar 2023

Medium riskHealth Canada
Watch Intuitive Surgical

An official Health Canada notice concerns Da vinci surgical systems. An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems. The loose instrument carriage is an outcome of a linear rail component being out of specification. The loose instrument carriage makes it possible for the carriage to wobble along the linear rail in response to force applied to the carriage or to the shaft of an installed instrument. Recall start date: February 23, 2023 Published 2023-03-09.

What to do now

CAPA 552131 started to address issue. Customers provided with further instructions in response.

Recall number

73120

Official notice

2023-03-09

The hazard

An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems. The loose instrument carriage is an outcome of a linear rail component being out of specification. The loose instrument carriage makes it possible for the carriage to wobble along the linear rail in response to force applied to the carriage or to the shaft of an installed instrument. Recall start date: February 23, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73120

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Affected products

Product 1

Affected products - Da Vinci X Surgical System Is4200, Lot or serial number - Contact manufacturer., Model or catalog number - PS4200

Product 2

Affected products - Da Vinci Xi Surgical System Is4000, Lot or serial number - Contact manufacturer, Model or catalog number - IS4000

Risk / hazard

An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems. The loose instrument carriage is an outcome of a linear rail component being out of specification. The loose instrument carriage makes it possible for the carriage to wobble along the linear rail in response to force applied to the carriage or to the shaft of an installed instrument. Recall start date: February 23, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Intuitive Surgical, Da Vinci Surgical

Manufacturer

Not provided

Phone

Not provided

Brand: Intuitive Surgical, Da Vinci Surgical.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73120

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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