FDA-Device2020-01-22Class II
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).
Suntech Medical, Inc.
Hazard
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.
Sold states
No US Distribution; Internationally distributed to France, S. America
Affected count
384 units
Manufactured in
507 Airport Blvd Ste 117, Morrisville, NC, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2020Don't want to check this manually?
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