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U.S. Department of Health and Human Services

Class 2 Device Recall Bravo Mini, Agilis Mini, NBP One, bloodpressure measurement system

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  Class 2 Device Recall Bravo Mini, Agilis Mini, NBP One, bloodpressure measurement system see related information
Date Initiated by Firm December 11, 2019
Create Date January 14, 2020
Recall Status1 Terminated 3 on April 10, 2023
Recall Number Z-0810-2020
Recall Event ID 84531
510(K)Number K151520  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
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).
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Suntech Medical, Inc.
507 Airport Blvd Ste 117
Morrisville NC 27560-8200
For Additional Information Contact Jeremy Denno
919-654-6143
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = SunTech Medical, Inc.
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