Z-0810-2020Class II

Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number...

Name: Z-0810-2020 Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number...
Creator: Suntech Medical, Inc.
Published: 2019-12-11
License: https://open.fda.gov/license/

Suntech Medical, Inc. / initiated 2019-12-11 / Terminated / root cause: design

FDA source

Suntech Medical, Inc. began a recall of Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124... on 2019-12-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0810-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-01-14
Terminated: 2023-04-10
Recalling firm: Suntech Medical, Inc.
Product: 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).
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: 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 tag: design
FDA 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 in commerce: 384 units
Distribution: No US Distribution; Internationally distributed to France, S. America
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-14

Product code DXN

K151520Class IIOscar 2Suntech Medical, Inc. / cleared 2016-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)