The Recall Desk
HighFDA (Devices)·Z-1700-2014·Announced 2014-06-11

Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch

Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Hologic, Inc. is recalling 11 units of the Selenia Full Field Digital Mammography System (models SEL-00002, SEL-00013, SEL-00030, and SEL-00039). The recall is due to a defective relay switch that may prevent the system from turning off if the emergency off switch is used. This malfunction could result in patient injury.

The affected units were distributed in Puerto Rico, the states of California, New York, and Texas, and the Republic of Korea. Specific serial numbers for the recalled units are listed in the official recall documentation.

Healthcare facilities and users of these systems should contact Hologic, Inc. for instructions on how to address the defect. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Manufacturer
Hologic, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Serial Numbers: 2840314W8065
  • 2840314W8062W
  • 2840314W8066W
  • 2840314W8067 2840314W8073
  • 2840314W8064
  • 2840314W8056W
  • 28401082720 28407083579
  • 28401137611W
  • 28403083045W

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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