Braemar Holter Software

Braemar Holter Software Download

Software inpage free download. CONTACT BRAEMAR. Interested in learning how we can meet your specific requirements? Contact us by mail, phone, fax, email or please complete the form below: Braemar 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121 USA Get driving directions. Lightning the queen games. Toll Free: 800.328.2719 Phone: 651.286.8620 Fax: 651.286.8630. Braemar’s state-of-the-art Monitors provide high quality ECG digital recording with no data compression. https://nitrobrooklyn.weebly.com/any-flac-converter-3-8-31.html. The DL900 Holter offers high sampling rate options and extended recording times along with a high speed USB and removable memory card. Removable Braemar certified compact flash cards for the DL800 and DL1200 make it easy to transfer data. Acorn 5 2 – bitmap image editor. Dvdvideosoft free studio serial key.

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Class 2 Device Recall DL900 Holter

Z-1459-2020
Date Initiated by Firm	January 22, 2020
Create Date	March 10, 2020
Recall Status¹	Open³, Classified

Recall Event ID

84883

K071733

Electrocardiograph, ambulatory (without analysis) - Product CodeMWJ

Product

Braemar Manufacturing LLC
DL900 Holter Monitor
1285 Corporate Center Dr.
Suite 150
Eagan, MN 55121 USA
Rx Only

Code Information

All devices manufactured or distributed prior to 01/01/2020 are affected.

Recalling Firm/
Manufacturer

Braemar Manufacturing, LLC
1285 Corporate Center Dr Ste 150
Eagan MN 55121-1278

For Additional Information Contact

JR Finkelmeir
651-286-8620

An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if 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. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.

Software design

Consignees notified via email with recall letter dated 01/22/2020. 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.

10582

Nationwide. No governmental consignees or Canadian consignees. International 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.

TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

510(K) Database

510(K)s with Product Code = MWJ and Original Applicant = BRAEMAR, INC.

Braemar Holter Software

Created at 2020-12-29 04:30

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