CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report
Fluoroscan Mini C-Arm recalled by Hologic
Hologic is recalling Hologic Fluoroscan Mini C-Arm, distributed nationwide in the US. The recall was initiated on 14 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2453-2012
- FDA event ID
- 63180
- Recalling firm
- Hologic, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2012
- FDA classified
- 25 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 14 Sep 2012 | Recall initiated by company | |
| 25 Sep 2012 | Classified by FDA | +11 days |
| 3 Oct 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
Questions about this recall
Is Fluoroscan Mini C-Arm recalled?
Yes. Hologic recalled Fluoroscan Mini C-Arm on 14 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-2453-2012.
Why was it recalled?
Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.
Which lots are affected?
Software version 5.0.1and 5.0.2
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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