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Recall Observatory FDA recall evidence

Device 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).

Z-0810-2020

December 11, 2019

Class II

Product summary

Firm
Suntech Medical, Inc.
Event
Event 84531
Status
Terminated
Classification
Class II
Quantity
384 units
Official record key
device-enforcement:Z-0810-2020

Official wording

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.

Code information: All serial numbers.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.