Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center… — Class II medical device recall Z-1459-2020
Terminated recall by Braemar Manufacturing, LLC, reported 2020-03-18, distributed nationwide. An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can pre
| Recall number | Z-1459-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Braemar Manufacturing, LLC, Eagan, MN, United States |
| Recall initiated | 2020-01-22 |
| Classified | 2020-03-10 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BO, CH, CZ, DE, ES, FI, FR, HK, IL, IT, LB, MX, SE, VN |
| Quantity | 10,582 |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1459-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.