Braemar Manufacturing LLC DL900 Holter Monitor 1285 recall: Software Issue
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Why was Braemar Manufacturing LLC DL900 Holter Monitor 1285 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All devices manufactured or distributed prior to 01/01/2020 are affected.
- Product
- Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
- Recalling firm
- Braemar Manufacturing, LLC
- Quantity
- 10582
- Distribution
- Nationwide. No governmental consignees or Canadian consignees. International distribution to Germany, Spain, Switzerland, France, Finland, Vietnam, Israel, France, Hong Kong, Czech Republic, Finland, Belgium, Sweden, Mexico, Lebanon, United Arab Emirates, Bolivia, Italy, and Belgium.
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)