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Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc. Recalls

All product recalls associated with Siemens Medical Solutions USA Inc..

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 601–620 of 1121 recalls

Siemens Medical Solutions USA Inc.: Biograph mCT S(64)-4R, System Material Number 10248672. ...

Possibility for system display freeze during CT interventional procedures.

Class IIModerate

FDANov 13, 2014IN, MA, NC• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Biograph mCT Flow 40-4R, System Material Number 10529159....

Possibility for system display freeze during CT interventional procedures.

Class IIModerate

FDANov 13, 2014IN, MA, NC• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Biograph mCT X-4R, System Material Number 10248670. Th...

Possibility for system display freeze during CT interventional procedures.

Class II

1...29 303132 33...57

Page 31 of 57Next

Moderate

FDANov 13, 2014IN, MA, NC• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Biograph mCT Flow Edge-4R, System Material Number 1052895...

Possibility for system display freeze during CT interventional procedures.

Class IIModerate

FDANov 13, 2014IN, MA, NC• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA Inc.: Biograph mCT S(40)-4R, System Material Number 10248671. ...

Possibility for system display freeze during CT interventional procedures.

Class IIModerate

FDANov 13, 2014IN, MA, NC• Siemens Medical Solutions USA Inc.

Siemens Medical Solutions USA, Inc: Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : ...

Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.

Class IIModerate

FDANov 11, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Mammomat Inspiration system: Product Usage: mammogra...

It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.

Class IIModerate

FDAOct 28, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens SimView NT and SimView NT with IDI simulation sys...

Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.

Class IIModerate

FDAOct 10, 2014Nationwide• Siemens Medical Solutions USA, Inc

Bausch & Lomb Inc- Greenville Solutions Plant: Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 f...

Product lot did not meet the specification for its disinfectants at the time of manufacture.

Class IIModerate

FDASep 25, 2014Nationwide• Bausch & Lomb Inc- Greenville Solutions Plant

Siemens Medical Solutions USA, Inc: Artis zeego systems, model number 10280959, with serial n...

A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.

Class IIModerate

FDASep 23, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Mammomat Inspiration mammography systems. The...

The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

Class IIModerate

FDASep 18, 2014IN, MA, NY +1 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis zee/ zeego systems, model numbers: 10094135, 10094...

The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.

Class IIModerate

FDASep 17, 2014CA, CO, CT +14 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Uroskop Omnia Max system The Uroskop Omnia is a...

Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

Class IIModerate

FDASep 2, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Luminos Agile Max system The Luminos Agile is i...

Class IIModerate

FDASep 2, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens AXIOM Luminos dRF Max systems The Axiom Lumino...

Class IIModerate

FDASep 2, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Ysio Max system The Ysio Max is a radiographic s...

Class IIModerate

FDASep 2, 2014Nationwide• Siemens Medical Solutions USA, Inc

Mckesson Information Solutions LLC: McKesson Cardiology" Hemo intended for complete physiolog...

Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.

Class IIModerate

FDAAug 27, 2014Nationwide• Mckesson Information Solutions LLC

Siemens Medical Solutions USA, Inc: The Ysio Systems with software version VC10 The Ysio e...

Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.

Class IIModerate

FDAAug 27, 2014Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc.: V5Ms Transesophageal transducers; V5Ms trans-esophage...

Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.

Class IIModerate

FDAAug 13, 2014Nationwide• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: The Siemens Symbia T series is intended for use by approp...

Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

Class IIModerate

FDAAug 12, 2014Nationwide• Siemens Medical Solutions USA, Inc.