Braemar Manufacturing, LLC: Medical Device Recall in 2020 - (Recall #: Z-1460-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 22, 2020

Date Posted: March 18, 2020

Recall Number: Z-1460-2020

Event ID: 84883

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.

Status: Terminated

Product Quantity: 10582

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated