Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x… recallZ-1326-2013 · Hologic, Inc. · initiated Apr 25, 2013
Class II Terminated All recalls posted in May 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1326-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 25, 2013
- Posted by the FDA
- May 17, 2013
- Recalling firm
- Hologic, Inc.
- Quantity
- 287
- Product code
- JAA
- FDA submissions
- K051025
- 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 description
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x 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.
Code information (models, lots, serial numbers)
Serial numbers per recall strategy.
Other devices under the same FDA submission
1 device cleared under K051025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- InSight 2Hologic, Inc. · System, x-ray, fluoroscopic, image-intensified1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 65028).
- Z-1327-2013 · TerminatedFluoroscan 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 fluorosc…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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