Recall Z-1459-2020
Braemar Manufacturing, LLC · initiated January 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Codes / lots: All devices manufactured or distributed prior to 01/01/2020 are affected.
Reason for recall
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.
FDA-determined cause: Software design
Action taken
Consignees notified via email with recall letter dated 01/22/2020. The letter identified affected product, stated reason for recall, and provided instructions on how to reset the error by following provided instructions, or to send the equipment to Braemar for repair.
Details
- Recall number
- Z-1459-2020
- Initiated
- January 22, 2020
- Terminated
- May 27, 2022
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- 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.
- Recalling firm
- Braemar Manufacturing, LLC, Eagan, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1460-2020 Class II | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150…An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can… | 01/22/2020Terminated |