ELEKTA UNITY (2019-07-16)

Starting date:

July 16, 2019

Posting date:

August 2, 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, Healthcare Professionals, Hospitals

Identification number:

RA-70583

Last updated: 2019-08-02

• Reason
• Affected products

Affected Products

ELEKTA UNITY

Reason

The instructions for use of Gadolinium-Based Contrast Agents (GBCA) must be consulted prior to using in Unity clinical workflows. A warning advising clinical users of this information is missing from the provided Unity clinical IFU.

Affected products