PlainRecalls

Siemens Medical Solutions USA, Inc

530 recalls on record · Latest: Feb 11, 2026

FDA Devices Moderate Jul 10, 2019

Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280

FDA Devices Moderate Jul 10, 2019

Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

FDA Devices Moderate Jul 10, 2019

SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inte…

FDA Devices Moderate Jul 10, 2019

Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

FDA Devices Moderate Jul 10, 2019

SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inten…

FDA Devices Moderate Jul 10, 2019

Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137

FDA Devices Moderate Jul 10, 2019

Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

FDA Devices Moderate Jul 10, 2019

SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inte…

FDA Devices Moderate Jul 10, 2019

Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

FDA Devices Moderate Jul 10, 2019

SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is i…

FDA Devices Moderate May 22, 2019

Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and b…

FDA Devices Moderate May 22, 2019

Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed …

FDA Devices Moderate May 22, 2019

Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed …

FDA Devices Moderate May 15, 2019

Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to …

FDA Devices Moderate May 8, 2019

SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Comput…

FDA Devices Moderate May 8, 2019

SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of p…

FDA Devices Moderate May 8, 2019

SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images…

FDA Devices Moderate May 1, 2019

Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression …

FDA Devices Moderate Mar 6, 2019

Sensis Vibe System, Model Number 11007642, with software version VD10B.

FDA Devices Moderate Jan 16, 2019

Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emi…

FDA Devices Moderate Dec 12, 2018

Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagno…

FDA Devices Moderate Nov 21, 2018

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for s…

FDA Devices Moderate Nov 21, 2018

ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed fo…

FDA Devices Moderate Nov 21, 2018

ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system develope…

FDA Devices Moderate Nov 7, 2018

Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic ex…

FDA Devices Moderate Nov 7, 2018

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

FDA Devices Moderate Nov 7, 2018

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomog…

FDA Devices Moderate Oct 24, 2018

Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64…

FDA Devices Moderate Sep 26, 2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

FDA Devices Moderate Aug 29, 2018

3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is movea…

FDA Devices Moderate Aug 29, 2018

3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the d…

FDA Devices Moderate Aug 22, 2018

ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed …

FDA Devices Moderate Aug 22, 2018

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of d…

FDA Devices Moderate Aug 8, 2018

SOMATOM Emotion 6 (Model 10165888)

FDA Devices Moderate Aug 8, 2018

SOMATOM Perspective 16 (Model 10891666)

FDA Devices Moderate Aug 8, 2018

SOMATOM Perspective (Model 10495568)

FDA Devices Moderate Aug 8, 2018

SOMATOM Scope Power (Model 10967888)

FDA Devices Moderate Aug 8, 2018

SOMATOM Spirit(Model 10045692 )

FDA Devices Moderate Aug 1, 2018

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

FDA Devices Moderate Aug 1, 2018

AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imagin…

FDA Devices Moderate Jul 4, 2018

Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jul 4, 2018

Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jul 4, 2018

Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jul 4, 2018

Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jul 4, 2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

FDA Devices Moderate Jul 4, 2018

Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jul 4, 2018

Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

FDA Devices Moderate Jun 6, 2018

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.

FDA Devices Moderate Jun 6, 2018

SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

FDA Devices Moderate May 30, 2018

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic i…