6/12/2023 0 Comments Braemar holter softwareInternational distribution to Germany, Spain, Switzerland, France, Finland, Vietnam, Israel, France, Hong Kong, Czech Republic, Finland, Belgium, Sweden, Mexico, Lebanon, United Arab Emirates, Bolivia, Italy, and Belgium.ġ A record in this database is created when a firm initiates a correction or removal action. No governmental consignees or Canadian consignees. The letter identified affected product, stated reason for recall, and provided instructions on how to reset the error by following provided instructions, or to send the equipment to Braemar for repair. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software.Įrror 602 may be able to be cleared by technical or engineering staff at the customer site.Ĭonsignees notified via email with recall letter dated. ![]() There are no actions that a clinical user can take to clear thisĮrror. ![]() ![]() ![]() This issue can prevent the recorder from operating normally.īraemar confirmed that beginning on Januif a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. Electrocardiograph, ambulatory (without analysis) - Product Code MWJĪll devices manufactured or distributed prior to are affected.Īn issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020.
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