PlainRecalls
FDA Devices Moderate Class II Terminated

Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

Reported: March 18, 2020 Initiated: January 22, 2020 #Z-1460-2020

Product Description

Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

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.

Details

Units Affected
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.
Location
Eagan, MN

Frequently Asked Questions

What product was recalled? ▼
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only. Recalled by Braemar Manufacturing, LLC. Units affected: 10582.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1460-2020.

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