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.
FDA Recall Z-2080-2012 · Posted None
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Recalling FirmBeekley Corporation
Recall StatusTerminated
Product CodeIZH
Date Initiated2012-07-02
Date Terminated2013-07-09
Product Quantity86,000 units
Reason for Recall
Imaging artifact can occur on mammogram result
Firm Action
Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539.
Root Cause
Nonconforming Material/Component
Distribution Pattern
International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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