Z-1701-2014Class II

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

Name: Z-1701-2014 Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For...
Creator: Hologic, Inc.
Published: 2014-05-13
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2014-05-13 / Terminated

FDA source

Hologic, Inc. began a recall of Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast on 2014-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1701-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-13
Posted: 2014-06-03
Terminated: 2014-08-18
Recalling firm: Hologic, Inc.
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.
Product code: IZH System, X-Ray, Mammographic
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
FDA root cause: Component change control
Action: Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express 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-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
Quantity in commerce: 3 units
Distribution: Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Product codes and lots: Serial Numbers: 1800314 7263, 180031472, 18002023051PR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03
Z-1701-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

Product code IZH

K011987Class IIModified M-IV Mammography SystemLorad, A Hologic Co. / cleared 2001-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)