Recall Z-1460-2020 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
Braemar Manufacturing, LLC
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
| Date | Jan 22, 2020 |
| Status | Terminated |
| Reason | 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. Err |
| Root cause | Software design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071733 | DL900 SERIES HOLTER RECORDER Braemar, Inc., Jul 24, 2007 |