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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device

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  Class 2 Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device see related information
Date Initiated by Firm February 27, 2017
Create Date April 11, 2017
Recall Status1 Terminated 3 on June 14, 2019
Recall Number Z-1777-2017
Recall Event ID 76552
510(K)Number K152770  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
Code Information Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620; Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.
Recalling Firm/
Manufacturer		 Welch Allyn Inc
4341 State Street Rd
Skaneateles Falls NY 13153-5300
For Additional Information Contact Maria Griffin
844-360-8220
Manufacturer Reason
for Recall		 A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
FDA Determined
Cause 2		 Other
Action Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017. All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed. For further questions, please call (844) 360-8220.
Quantity in Commerce 981 units
Distribution Worldwide Distribution - USA (nationwide) Distribution
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 = MICROLIFE INTELLECTUAL PROPERTY GMBH
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