RecallRadar

FDA Device recall Z-1701-2014

Hologic M-IV Mammography System

On 2014-06-11 the FDA classified a Class II recall of Hologic M-IV Mammography System by Hologic, citing selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1701-2014
ClassificationClass II
Statusterminated
Initiated2014-05-13
Published2014-06-11
Last updated2026-09-13 11:53 UTC
CompanyHologic
DistributionCA, NY, PR, TX

Product

Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

Reason

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

Identifiers

code_infoSerial Numbers: 1800314 7263, 180031472, 18002023051PR

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2014%22

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