Siemens—Artis Systems with A100G Generators: Module in High-Voltage Generator May Fail

April 5, 2017 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a February 22, 2017, Customer Safety Advisory Notice letter submitted by an ECRI Institute member hospital, Siemens states that a module in the high-voltage generator of the above systems may fail with age. Siemens also states that if this failure occurs, the system responds by providing emergency fluoroscopy. Siemens further states that a spontaneous failure of the radiation generation function could occur, which may necessitate canceling or restarting treatment or transferring the patient to another system. Siemens further states that in the event of spontaneous failure, the fault can be rectified only by the firm's service organization. Siemens states that it has received no reports of either of these scenarios occurring. The manufacturer has not confirmed the...

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