Braemar recalls DL900 Holter Monitors made before Jan 1, 2020 that display Error 602 when starting new patient studies. The device may not function properly but stored ECG data can still be downloaded.
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 DL900 Holter Monitors made before January 1, 2020 because they sometimes display Error 602 when starting a new patient study. This prevents the device from working correctly for new studies but existing ECG recordings can still be downloaded.
The device displays Error 602 when a AAA battery is inserted and the user tries to start a new patient study. This prevents the monitor from functioning for new studies but does not affect existing ECG recordings stored on the device.
Healthcare providers using the DL900 Holter Monitors made before January 1, 2020 are affected. Patients using these monitors for cardiac monitoring are at low risk since existing ECG data remains accessible.
Check for the DL900 Holter Monitor model with a serial number or date code. Devices manufactured or distributed before January 1, 2020 are affected.
If the monitor displays Error 602 when starting a new patient study, 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 the manufacturer does not provide a fix for end users.
The recall applies to devices made before January 1, 2020, but no specific deadline is mentioned for action.
We’ve drafted a message you can send Braemar to request your refund or repair — edit it as you like.
Subject: Recall Z-1459-2020 — Braemar Braemar Hello, I own a Braemar that is covered by recall Z-1459-2020 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.
