FDA-Device2012-08-01Class II

Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

Beekley Corporation
Hazard

Imaging artifact can occur on mammogram result

Sold states
International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Affected count
86,000 units
Manufactured in
1 Prestige Ln, Bristol, CT, United States
Products
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2080-2012

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