| Class 2 Device Recall S4 |  |
Date Initiated by Firm | March 18, 2020 |
Date Posted | April 29, 2020 |
Recall Status1 |
Completed |
Recall Number | Z-1815-2020 |
Recall Event ID |
85297 |
510(K)Number | K160685 |
Product Classification |
Electrocardiograph - Product Code DPS
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Product | S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY.
The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network. |
Code Information |
Model Numbers: S4-Q-ASX-XXX, S4-Q-AXX-XXX, S4-P-A, 9293-061-50, 9293-061-51, 9293-061-52, 9293-061-53. |
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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