Z-1327-2013Class II

Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm...

Name: Z-1327-2013 Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm...
Creator: Hologic, Inc.
Published: 2013-04-25
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2013-04-25 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians... on 2013-04-25. FDA classified it as Class II and gives the reason as "The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1327-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2013-05-17
Terminated: 2014-08-21
Recalling firm: Hologic, Inc.
Product: Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Hologic, Inc. sent an "Urgent: Medical Device Recall" letter dated April 25, 2013, via FedEx to consignees/customers notifying them of the software defect and providing them with corrected user installable software version. The customers were instructed to complete and return the Enclosure to Customer Notification, Confirmation of Notification form via fax to Hologic at 866-652-8674 or mail the document to Hologic using the enclosed pre-addressed, pre-paid return envelope. Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.
Quantity in commerce: 2780
Distribution: Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.
Product codes and lots: Serial numbers per recall strategy.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1327-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1326-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16
Z-1327-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16

Product code JAA

K051025Class IIFluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. / cleared 2005-05-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)