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Selenia Full Field Digital Mammography System with software… recallZ-2301-2013 · Hologic, Inc. · initiated Sep 6, 2013

Class II Terminated All recalls posted in September 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-2301-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 6, 2013
Posted by the FDA
Sep 30, 2013
Recalling firm
Hologic, Inc.
Quantity
62 systems
Product code
MUE
FDA submissions
P010025
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 Taiwan.

Product description

Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography

Code information (models, lots, serial numbers)

Software versions 5.0.x and 5.1.x

Other devices under the same FDA submission

5 devices cleared under P010025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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