Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
FDA Recall Z-1460-2020 · Posted None
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Recalling FirmBraemar Manufacturing, LLC
Recall StatusTerminated
Product CodeMWJ
Date Initiated2020-01-22
Date Terminated2022-05-27
Product Quantity10582
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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