CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Ziehm Vision R. Iterventional fluoroscopic x-ray system recalled
Orthoscan is recalling Ziehm Vision R. Iterventional fluoroscopic x-ray system, distributed in Puerto Rico. The recall was initiated on 8 Aug 2024 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-0577-2025
- FDA event ID
- 95709
- Recalling firm
- Orthoscan, Scottsdale, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2024
- FDA classified
- 2 Dec 2024
- Reported
- 11 Dec 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 8 Aug 2024 | Recall initiated by company | |
| 2 Dec 2024 | Classified by FDA | +116 days |
| 11 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
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
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Where it was distributed
U.S. (including Puerto Rico).
Questions about this recall
Why was it recalled?
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
Which lots are affected?
UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.
Where was it sold?
U.S. (including Puerto Rico).
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 95709This product is part of a recall event; the main page for the event is Ziehm Solo. Digital Mobile C-arm recalled by Orthoscan.
More recalls from Orthoscan
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ziehm Vision FD. Interventional fluoroscopic x-ray system recalled | Orthoscan | Device Malfunction | PR |
| Device | CLASS II | Ziehm Vision RFD 3D recalled by Orthoscan | Orthoscan | Device Malfunction | PR |
| Device | CLASS II | Ziehm Vision system, x-ray, tomography, computed recalled by Orthoscan | Orthoscan | Device Malfunction | PR |
| Device | CLASS II | Ziehm Vision RFD recalled by Orthoscan | Orthoscan | Device Malfunction | PR |
| Device | CLASS II | Ziehm Solo FD. Interventional fluoroscopic x-ray system recalled | Orthoscan | Device Malfunction | PR |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |