Braemar DL900 Holter Monitor Recalled for Operational Failure
Braemar Manufacturing is recalling DL900 Holter Monitors because a software issue prevents new patient studies from starting. Existing recordings can still be downloaded.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure that prevents new studies but does not pose a direct physical safety risk like injury or death, fitting the criteria for moderate severity.
Plain-English summary
Braemar Manufacturing, LLC is recalling the DL900 Holter Monitor. The recall affects 10,582 units manufactured or distributed prior to January 1, 2020. The devices were distributed nationwide and internationally to countries including Germany, Spain, Switzerland, France, Finland, Vietnam, Israel, Hong Kong, Czech Republic, Belgium, Sweden, Mexico, Lebanon, United Arab Emirates, Bolivia, and Italy.
The recall was initiated because a specific issue recognized on January 1, 2020, can prevent the recorder from operating normally. If a AAA battery is inserted and a user attempts to start the device, it displays "Error: 602" and fails to function for new patient studies. Clinical users cannot clear this error themselves, though technical or engineering staff at the customer site may be able to do so. Despite this error, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software.
Healthcare providers should contact Braemar Manufacturing for instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
- Manufacturer
- Braemar Manufacturing, LLC
- Category
- Medical Device — Cardiology
- Hazard
- Affected units
- 10,582
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All devices manufactured or distributed prior to 01/01/2020 are affected.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Braemar Manufacturing, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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