Exact FDA event identifier

Event 68298

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 13, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hologic, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1700-2014

Recall number: Z-1700-2014
Initiated: May 13, 2014
Classification: Class II
Status: Terminated
Recalling firm: Hologic, Inc.
Quantity: 11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

device · product 2 of 2

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

Z-1701-2014

Recall number: Z-1701-2014
Initiated: May 13, 2014
Classification: Class II
Status: Terminated
Recalling firm: Hologic, Inc.
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 1800314 7263, 180031472, 18002023051PR

Distribution pattern

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.