Siemens Medical Solutions USA, Inc recall records

141 reported ongoing

162 records in this archive. Latest source date Jun 8, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane...

Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135...
FDA device enforcement

ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR C...

On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, O...

Official source for ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic ...
FDA device enforcement

ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G

On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, O...

Official source for ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to...
FDA device enforcement

ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A

On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, O...

Official source for ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, run...
FDA device enforcement

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movemen...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egy...

Official source for ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
FDA device enforcement

Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

Class IIReported ongoing

Distribution: Nationwide

Official source for Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical envir...
FDA device enforcement

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Mate...

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

Class IIReported ongoing

Distribution: Nationwide

Official source for ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for t...
FDA device enforcement

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used wit...

In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headb...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM...
FDA device enforcement

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of IL, WI, CA, NM, TX, NC, MI, MD, NY, OH, IN, NE, PA, LA, SC, MO, OK, VA, ME, AZ, PR, IA, NH, NJ, AR, FL, SD and ...

Official source for ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
FDA device enforcement

The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b...

During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction ...

Class IIReported ongoing

Distribution: Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, ...

Official source for The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD ...
FDA device enforcement

ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the sy...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Ho...

Official source for ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and ...
FDA device enforcement

ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the sy...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Ho...

Official source for ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and int...
FDA device enforcement

ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the sy...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Ho...

Official source for ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and intervent...
FDA device enforcement

Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in ...

Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass droppi...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY and the countries of Austria, Bangladesh, Brazil, Canada, China, Croatia, El Salvador, France, Ger...

Official source for Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology...
FDA device enforcement

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia...

Official source for ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interve...
FDA device enforcement

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-...

Reasons in these listed records

  • Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
  • Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a si...
  • On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not...
  • The possibility of the Sensis documentation functionality application to crash.

These examples come from this result page and are not a ranking of every recall reason.

Checking Siemens Medical Solutions USA, Inc

Is there a recall on siemens medical solutions usa, inc right now?

This archive contains 162 records, including 141 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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