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Terminated

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).

FDA Recall Z-0810-2020 · Posted None

Recalling FirmSuntech Medical, Inc.
Recall StatusTerminated
Product CodeDXN
Date Initiated2019-12-11
Date Terminated2023-04-10
Product Quantity384 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

No US Distribution; Internationally distributed to France, S. America

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151520Oscar 2Suntech Medical, Inc. · 2016-02-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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