| Class 2 Device Recall Bravo Mini, Agilis Mini, NBP One, bloodpressure measurement system | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXN
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