No image published for this recall

No image published for this recall

Philips achieva, intera and ingenia systems

Official notice

17 Jan 2024

Last checked

17 Jan 2024

High riskHealth Canada

An official Health Canada notice concerns Philips achieva, intera and ingenia systems. The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is a rubber seal that is glued between the cone cover and QBC cover and functions to prevent sharp edges of the QBC cover from contacting patients during an examination. Recall start date: January 9, 2024 Published 2024-01-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74922

Official notice

2024-01-17

The hazard

The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is a rubber seal that is glued between the cone cover and QBC cover and functions to prevent sharp edges of the QBC cover from contacting patients during an examination. Recall start date: January 9, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74922

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Affected products

Product 1

Affected products - Achieva XR System-Main Unit, Lot or serial number - Not applicable., Model or catalog number/ - ACHIEVA XR

Product 2

Affected products - Achieva 3.0T MRI System-Main Unit, Lot or serial number - Not applicable., Model or catalog number/ - ACHIEVA 3.0T

Product 3

Affected products - Intera 1.5T MRI System-Main Unit, Lot or serial number - Not applicable., Model or catalog number/ - INTERA 1.5T

Product 4

Affected products - Achieva 1.5T MRI System-Main Unit, Lot or serial number - Not applicable., Model or catalog number/ - ACHIEVA 1.5T

Product 5

Affected products - Ingenia 3.0T, Lot or serial number - Not applicable., Model or catalog number/ - 3.0T

Risk / hazard

The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is a rubber seal that is glued between the cone cover and QBC cover and functions to prevent sharp edges of the QBC cover from contacting patients during an examination. Recall start date: January 9, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Philips.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

74922

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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