Siemens Healthcare Diagnostics Inc Recalls

Siemens Medical Solutions USA, Inc: LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Imp...

A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry XPT interfaced to the CentraLink Data Ma...

Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.

Siemens Medical Solutions USA, Inc: Ysio Max, Luminos dRF Max and Agile Max systems with soft...

Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.

Siemens Medical Solutions USA, Inc: SOMATOM Force; the intended use of computed tomography is...

Artifacts are found in acquired imaging on the SOMATOM Force.

Siemens Medical Solutions USA, Inc: Artis Q, and Artis Q.zen ceiling systems; model numbers: ...

Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.

Siemens Medical Solutions USA, Inc: Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, O...

Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD08...

Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.

Siemens Medical Solutions USA, Inc: ARTISTE MV System, Linear Accelerator (LINAC) with SysVC...

There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

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

Possibility for system display freeze during CT interventional procedures.

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

Possibility for system display freeze during CT interventional procedures.

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

Possibility for system display freeze during CT interventional procedures.

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

Possibility for system display freeze during CT interventional procedures.

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

Possibility for system display freeze during CT interventional procedures.

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.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista 500 Intelligent Lab System or Dimension V...

Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

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.

Siemens Healthcare Diagnostics, Inc.: Turbo Troponin I For in vitro diagnostic use for the q...