3.0 T and 1.5HD Small Extremity Wrist Coil (2019-10-16)

Starting date:

October 16, 2019

Posting date:

November 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71473

Last updated: 2019-11-01

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  Reason
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  Affected products

Affected Products

1. 3.0T Small Extremity Wrist Coil
2. 1.5T HD Small Extremity Wrist Coil

Reason

The "Small Extremity Wrist Coil", manufactured by Medspira LLC, and previously by Mayo Medical Ventures, was distributed by GE Healthcare in Canada. GE Healthcare has recently become aware that this device is not licenced by Health Canada. Medspira LLC does not intend to obtain a medical device licence for the product in Canada.

Affected products