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U.S. Department of Health and Human Services

Class 2 Device Recall H12

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  Class 2 Device Recall H12 see related information
Date Initiated by Firm March 18, 2020
Date Posted April 29, 2020
Recall Status1 Open3, Classified
Recall Number Z-1812-2020
Recall Event ID 85297
510(K)Number K050896  
Product Classification Electrocardiograph - Product Code DPS
Product H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP.

The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage.
Code Information Model Numbers: H12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51. 
Recalling Firm/
Manufacturer		 WELCH ALLYN, INC/MORTARA
7865 N 86th St
Milwaukee WI 53224-3431
For Additional Information Contact
888-667-8272
Manufacturer Reason
for Recall		 Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
FDA Determined
Cause 2		 Device Design
Action Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed.
Quantity in Commerce 78,521 units total
Distribution US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = MORTARA INSTRUMENT, INC.
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