Z-1460-2020Class II

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

Name: Z-1460-2020 Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Creator: Braemar Manufacturing, LLC
Published: 2020-01-22
License: https://open.fda.gov/license/

Braemar Manufacturing, LLC / initiated 2020-01-22 / Terminated / root cause: software

FDA source

Braemar Manufacturing, LLC began a recall of Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only on 2020-01-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1460-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-22
Posted: 2020-03-10
Terminated: 2022-05-27
Recalling firm: Braemar Manufacturing, LLC
Product: Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Product code: MWJ Electrocardiograph, Ambulatory (Without Analysis)
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: All devices manufactured or distributed prior to 01/01/2020 are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1459-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10
Z-1460-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10

Product code MWJ

K071733Class IIDl900 Series Holter RecorderBraemar, Inc. / cleared 2007-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)