# FDA recall Z-1459-2020

> **Braemar Manufacturing, LLC** · Class II · device recall initiated 2020-01-22.

## Product

Braemar Manufacturing LLC  DL900 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.

## 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.

## Key facts

- **Recall number:** Z-1459-2020
- **Recalling firm:** Braemar Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-22
- **Report date:** 2020-03-18
- **Termination date:** 2022-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eagan, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2020

## Citation

> AI Analytics. FDA recall Z-1459-2020. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-1459-2020. Source: US FDA. Licensed CC0.

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