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
Affected Products
- 3.0T Small Extremity Wrist Coil
- 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
A. 3.0T Small Extremity Wrist Coil
Lot or serial number
All lots.
Model or catalog number
BC-10-3.0T
Companies
- Manufacturer
-
Medspira LLC
2718 Summer Street NE
Minneapolis
55413
Minnesota
UNITED STATES
B. 1.5T HD Small Extremity Wrist Coil
Lot or serial number
All lots.
Model or catalog number
BC-10-1.5T
Companies
- Manufacturer
-
Medspira LLC
2718 Summer Street NE
Minneapolis
55413
Minnesota
UNITED STATES