CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report

Somatom Perspective, Computed tomography x-ray system recalled

Siemens Medical Solutions USA is recalling Somatom Perspective, Computed tomography x-ray system, distributed in 8 states. The recall was initiated on 22 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # 10967888 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451

Quantity recalled13 systems

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-0921-2017
FDA event ID: 75860
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2016
FDA classified: 23 Dec 2016
Reported: 4 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

22 Nov 2016	Recall initiated by company
23 Dec 2016	Classified by FDA	+31 days
4 Jan 2017	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

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

SOMATOM Perspective, Computed tomography x-ray system

Where it was distributed

Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Arkansas Georgia Illinois Maryland Michigan New York South Carolina South Dakota

Questions about this recall

Is Somatom Perspective, Computed tomography x-ray system recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Perspective, Computed tomography x-ray system on 22 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0921-2017.

Why was it recalled?

Which lots are affected?

Model # 10967888 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451

Where was it sold?

Distributed to: IL IL GA SC SD OK NY MI IN MD AR

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.

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 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals