CLASS II Device recall · Reported 14 Oct 2015 · FDA Enforcement Report

Somatom Definition Flash recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Definition Flash, distributed nationwide in the US. The recall was initiated on 14 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 73459 74191 73487 73492 73494 73497 73013 73657 73535 73667 73490 73513 74192 73697 73635 73471 73405 73600 73558 73591 73546 73478 73504 73413 73674 73445 73547 73420 73430

Quantity recalled113 total

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-0020-2016
FDA event ID: 72091
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Aug 2015
FDA classified: 5 Oct 2015
Reported: 14 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

14 Aug 2015	Recall initiated by company
5 Oct 2015	Classified by FDA	+52 days
14 Oct 2015	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

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

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

SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Somatom Definition Flash recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Definition Flash on 14 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0020-2016.

Why was it recalled?

Which lots are affected?

Model# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 73459 74191 73487 73492 73494 73497 73013 73657 73535 73667 73490 73513 74192 73697 73635 73471 73405 73600 73558 73591 73546 73478 73504 73413 73674 73445 73547 73420 73430

Where was it sold?

Nationwide Distribution.

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