Braemar DL950 Holter Monitor Recall Due to Startup Error
Braemar Manufacturing is recalling DL950 Holter Monitors because a software issue prevents new patient studies from starting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 preventing new studies, but existing data remains accessible and no injuries or illnesses are reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Braemar Manufacturing, LLC is recalling DL950 Holter Monitors. The recall affects 10,582 units manufactured or distributed prior to January 1, 2020. These devices are distributed nationwide and internationally to various countries.
The recall was initiated because the recorder may display "Error: 602" and fail to function for new patient studies when a AAA battery is inserted and the user attempts to start the device. This issue was recognized on January 1, 2020. Clinical users cannot clear this error, though existing ECG recordings can still be downloaded. Technical or engineering staff may be able to clear the error.
Healthcare providers and patients should contact Braemar Manufacturing for instructions on how to resolve the issue or obtain a replacement.
The recalled product
- Product
- Braemar Manufacturing LLC DL950 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.
See all 2 products in this recall →Related recalls
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