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U.S. Department of Health and Human Services

Class 2 Device Recall DL950 Holter

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  Class 2 Device Recall DL950 Holter see related information
Date Initiated by Firm January 22, 2020
Create Date March 10, 2020
Recall Status1 Terminated 3 on May 27, 2022
Recall Number Z-1460-2020
Recall Event ID 84883
510(K)Number K071733  
Product Classification Electrocardiograph, ambulatory (without analysis) - Product Code MWJ
Product Braemar Manufacturing LLC
DL950 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
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 10582
Distribution 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.
Total Product Life Cycle 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWJ and Original Applicant = BRAEMAR, INC.
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