Manufacturer

Siemens Medical Solutions USA, Inc

156 recalls in our database name Siemens Medical Solutions USA, Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 156

HighFDA (Devices)·Z-0997-2022·2022-05-04
CT Scanner Software Update May Display Incorrect Laser Positioning Coordinates
Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.
Product
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2022·2022-04-27
Medical imaging system software errors may delay treatment procedures
Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.
Product
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2022·2022-04-27
Siemens Artis zee biplane X-ray system cooling defect recall
Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.
Product
Artis zee biplane, Model Number 10094141
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2022·2022-04-27
Artis Q zeego X-ray system recalled for inadequate cooling risk
Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.
Product
Artis Q zeego, Model Number 10848283
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2022·2022-04-27
X-ray Imaging System Coolant Deficiency May Disable Equipment Operation
The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.
Product
Artis Q ceiling, Model Number 10848281
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2022·2022-04-27
Medical X-ray imaging system recalled for cooling circuit malfunction
Siemens' Artis zee X-ray imaging systems may have inadequate cooling if the coolant level drops, potentially causing X-ray tube overheating. The system displays warnings and blocks X-ray operation to prevent equipment damage.
Product
Artis zee multi-purpose, Model Number 10094139
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2022·2022-04-27
Diagnostic imaging system software malfunction may interrupt clinical procedures
Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.
Product
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2022·2022-04-27
Artis zeego X-ray imaging system recalled for insufficient cooling
Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.
Product
Artis zeego, Model Number 10280959
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2022·2022-04-27
Artis Q floor X-ray system cooling failure poses overheating risk
Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.
Product
Artis Q floor, Model Number 10848280
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2022·2022-04-27
Artis zee floor X-ray systems recalled for cooling system failure
Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.
Product
Artis zee floor, Model Number 10094135
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2022·2022-04-27
Siemens Artis pheno diagnostic imaging system software malfunction recall
Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.
Product
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2022·2022-04-27
Artis Q biplane X-ray systems cooling failure may prevent adequate tube cooling
Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic system shutdown.
Product
Artis Q biplane, Model Number 10848282
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2022·2022-04-27
X-ray Imaging System May Fail to Cool Tube Properly
Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.
Product
Artis zee biplane MN, Model Number 10094143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2022·2022-04-27
CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation
Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.
Product
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2022·2022-04-27
Medical device X-ray imaging system recalled for cooling failure
Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.
Product
Artis Q.zen floor, Model Number 10848353
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2022·2022-04-27
Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk
Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.
Product
Artis Q.zen ceiling, Model Number 10848354
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0980-2022·2022-04-27
Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall
Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.
Product
Artis Q.zen biplane, Model Number 10848355
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0971-2022·2022-04-27
X-Ray Imaging System Cooling Circuit Failure Recall
Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.
Product
Artis zee floor MN, Model Number 10094142
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0968-2022·2022-04-27
X-ray Imaging System Cooling Failure May Cause Tube Overheating
Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.
Product
Artis zee ceiling, Model Number 10094137
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2022·2022-04-13
X-ray system displays incorrect collimation area information
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Product
YSIO X.Pree
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0841-2022·2022-04-06
Radiographic system software error may cause unintended tube stand movement
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Product
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2022·2022-02-02
Artis icono diagnostic imaging system software defects recalled nationwide
Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.
Product
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2022·2022-02-02
Diagnostic Imaging Angiography System Software Defects Recalled by Siemens
Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.
Product
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2022·2022-02-02
Siemens Diagnostic Angiography System Recalled for Multiple Software Defects
Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.
Product
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2022·2022-01-26
FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.
Product
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic
Category
Medical Device
Distribution
Distributed nationwide