CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report

Ziehm Solo. Digital Mobile C-arm recalled by Orthoscan

Orthoscan is recalling Ziehm Solo. Digital Mobile C-arm, distributed in Puerto Rico. The recall was initiated on 8 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.

Quantity recalled28

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-0573-2025
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: Other Medical Devices

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 Solo. Digital Mobile C-arm

Where it was distributed

U.S. (including Puerto Rico).

Puerto Rico

Questions about this recall

Is Ziehm Solo. Digital Mobile C-arm recalled?

Yes. Orthoscan recalled Ziehm Solo. Digital Mobile C-arm on 8 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0573-2025.

Why was it recalled?

Which lots are affected?

UDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.

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 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.

More recalls from Orthoscan

All 11

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Device	CLASS II	Ziehm Vision FD recalled by Orthoscan	Orthoscan	Device Malfunction	PR
11 Dec 2024Device	CLASS II	Ziehm Vision RFD 3D recalled by Orthoscan	Orthoscan	Device Malfunction	PR
11 Dec 2024Device	CLASS II	Ziehm Vision R recalled by Orthoscan	Orthoscan	Device Malfunction	PR
11 Dec 2024Device	CLASS II	Ziehm Vision system, x-ray, tomography, computed recalled by Orthoscan	Orthoscan	Device Malfunction	PR
11 Dec 2024Device	CLASS II	Ziehm Vision RFD recalled by Orthoscan	Orthoscan	Device Malfunction	PR

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