Events

Field Safety Notices about Siemens Z6Ms transesophageal transducer

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Medical Solutions USA, Inc. .

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    We have received reports about "acquisition errors" and the deterioration of material covering the articulating section of the z6ms transesophageal transducer. to date, no patient injury has been reported, and we believe the risk of injury to be remote. however, "acquisition errors" can cause a delay in the study for patients who are consciously sedated and possibly expose the patient to a second intubation. also, a compromise or fault in the transducer s material, combined with a failure to use a transducer sheath as directed in the user manual, may cause esophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient. .

Device

Siemens Z6Ms transesophageal transducer
  • Model / Serial
    63029009 63029015 63029016 63229003 63229007 63229008 63229011 63229012 63230002 63230003 63230009 63260584 63260585 63319012 63322007 63325007 63328003 63328007 63329017 63329018 63332002 63332004 63360611 63360612 63430519 63430524 63432007 63432010 63432015 63432017 63530515 63530516 63530518
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS