Braemar recalls DL950 Holter Monitors made before January 1, 2020 that may display Error 602 and fail to start new patient studies with AAA batteries.
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.
Braemar is recalling DL950 Holter Monitors made before January 1, 2020 because they may show Error 602 when starting a new patient study with a AAA battery. This prevents the device from working properly for new tests but existing recordings can still be downloaded.
The device may display Error 602 when starting a new patient study with a AAA battery, causing it to fail to function. This issue only affects new studies, not existing recordings which can still be downloaded.
Healthcare providers using Braemar DL950 Holter Monitors made before January 1, 2020 are affected. Patients are not at risk as existing recordings can still be downloaded.
Check for the DL950 Holter Monitor model with a serial number or date code. Devices made before January 1, 2020 are affected.
If the device displays Error 602 when starting a new patient study with a AAA battery, it is affected.
Yes, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software.
Technical or engineering staff at the customer site may be able to clear Error 602, but this is not a standard user action.
Braemar recognized the issue on January 1, 2020.
We’ve drafted a message you can send Braemar to request your refund or repair — edit it as you like.
Subject: Recall Z-1460-2020 — Braemar Braemar Hello, I own a Braemar that is covered by recall Z-1460-2020 from Braemar. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
