Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mamm

FDA device recall Z-2301-2013 · posted 2013-09-30 · Terminated

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

Action taken

Hologic sent an Urgent Medical Device Recall letter dated September 5, 2013, by Certified Mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised how to avoid loss of images until Hologic corrects the problem. A software upgrade to customers who are connected to Hologic Connect who have already been connected remotely and customers who have already been connected via a Service Call will receive notification of the problem and the date the system was remotely corrected notified by Certified Mail. A Dealer notification issued by certified mail to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00072. Selenia software version 5.2 will implement a double safeguard to both guarantee a 28 day retention period, as well as ensure images are removed in a least recently used order. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.

Root cause

Software design

Status

Terminated

Product code

MUE

Quantity affected

62 systems

Distribution

Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwa

Date initiated

2013-09-06

Date posted

2013-09-30

Date terminated

2013-12-13

Location

Danbury, CT