Device recall: Ziehm Solo. Digital Mobile C-arm
Class II FDA enforcement event 95709. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Orthoscan, Inc. started this device recall on 8 Aug 2024. The firm address in the FDA record is in Scottsdale, AZ. FDA put the recall in Class II. FDA event 95709 has 7 product records. The first FDA enforcement report date is 11 Dec 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S. (including Puerto Rico).
Recalling firm
Orthoscan, Inc., Scottsdale, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0573-2025 | Ziehm Solo. Digital Mobile C-arm | 28 | Class II | Ongoing | 11 Dec 2024 |
| Z-0574-2025 | Ziehm Solo FD. Interventional fluoroscopic x-ray system | 25 | Class II | Ongoing | 11 Dec 2024 |
| Z-0575-2025 | Ziehm Vision system, x-ray, tomography, computed. | 3 | Class II | Ongoing | 11 Dec 2024 |
| Z-0576-2025 | Ziehm Vision FD. Interventional fluoroscopic x-ray system | 22 | Class II | Ongoing | 11 Dec 2024 |
| Z-0577-2025 | Ziehm Vision R. Iterventional fluoroscopic x-ray system | 5 | Class II | Ongoing | 11 Dec 2024 |
| Z-0578-2025 | Ziehm Vision RFD. Interventional fluoroscopic x-ray system | 30 | Class II | Ongoing | 11 Dec 2024 |
| Z-0579-2025 | Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system | 50 | Class II | Ongoing | 11 Dec 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 7Median of the firm: 7
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Aug 2017 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-0573-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95709. https://recallregister.com/fda/ii/95709/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S. (including Puerto Rico).
- What quantity of product is in FDA event 95709?
- The event has 7 product records. The first record gives this quantity:
28
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.