CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report

interventional fluoroscopic x-ray system recalled

Siemens Medical Solutions USA is recalling interventional fluoroscopic x-ray system. The recall was initiated on 15 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes4056869063317

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-2020-2025
FDA event ID: 97135
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 15 May 2025
FDA classified: 27 Jun 2025
Reported: 9 Jul 2025
Type: FDA Mandated
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

15 May 2025	Recall initiated by company
27 Jun 2025	Classified by FDA	+43 days
9 Jul 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

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

interventional fluoroscopic x-ray system

Where it was distributed

Worldwide.

Questions about this recall

Why was it recalled?

Which lots are affected?

4056869063317

Where was it sold?

Worldwide.

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

3 other products · FDA event 97135

Reported	Class	Recall	Company	Reason	Where
9 Jul 2025	CLASS II	interventional fluoroscopic x-ray system recalled	Siemens Medical Solutions USA	Device Malfunction	PA
9 Jul 2025	CLASS II	interventional fluoroscopic x-ray system recalled	Siemens Medical Solutions USA	Device Malfunction	PA
9 Jul 2025	CLASS II	Artis is a family of dedicated angiography systems recalled	Siemens Medical Solutions USA	Device Malfunction	PA

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide