Recall Z-0810-2020 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Suntech Medical, Inc.
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
| Date | Dec 11, 2019 |
| Status | Terminated |
| Reason | The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product. |
| Root cause | Device Design |
| Action | Consignees notified via email with recall letter dated 12/11/2019. The letter identified affected product, stated reason for recall, and requested product not to be used, and to be returned to the distributor. A Recall Acknowledgement Form was requested to be returned by e-mail. |
| Quantity | 384 units |
| Distribution | No US Distribution; Internationally distributed to France, S. America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151520 | Oscar 2 Suntech Medical, Inc., Feb 19, 2016 |