| Class 2 Device Recall ELI PC | |
Date Initiated by Firm | March 18, 2020 |
Date Posted | April 29, 2020 |
Recall Status1 |
Completed |
Recall Number | Z-1811-2020 |
Recall Event ID |
85297 |
510(K)Number | K093339 |
Product Classification |
Electrocardiograph - Product Code DPS
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Product | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. |
Code Information |
Model Numbers: 11066-XXX-50, 41000-029-XX. |
Recalling Firm/ Manufacturer |
WELCH ALLYN, INC/MORTARA 7865 N 86th St Milwaukee WI 53224-3431
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DPS
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