ORTHOPANTOMOGRAPH OP 3D (2019-01-17)

Starting date:

January 17, 2019

Posting date:

May 3, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-69726

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

ORTHOPANTOMOGRAPH OP 3D

Reason

ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1, which can result in equivalent to, but not to exceed, radiation exposure (effective dose area) for a 9X7 FOV and 9X9 FOV, respectively. Based on Health Hazard Evaluation (HHE) and associated risk assessment defective devices have been determined to be safe and not increasing a risk of immediate or long-term health consequences. Ultimately the exposure is less than the effective dose areas of the 9X11 FOV or 9X14 FOV selections and will not result in any injury to the operator or patient. Furthermore, there is no effect on image quality or diagnostics of the X-ray image.

Affected products