Philips Achieva, Intera and Ingenia Systems
Last updated
Summary
Product
Philips Achieva, Intera and Ingenia Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number/ |
|---|---|---|
| Achieva XR System-Main Unit | Not applicable. | ACHIEVA XR |
| Achieva 3.0T MRI System-Main Unit | Not applicable. | ACHIEVA 3.0T |
| Intera 1.5T MRI System-Main Unit | Not applicable. | INTERA 1.5T |
| Achieva 1.5T MRI System-Main Unit | Not applicable. | ACHIEVA 1.5T |
| Ingenia 3.0T | Not applicable. | 3.0T |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74922
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