S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA G
FDA device recall Z-1815-2020 · posted 2020-04-29 · Terminated
Recall details
- Recalling firm
- WELCH ALLYN, INC/MORTARA
- Reason for recall
- Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 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,
- Date initiated
- 2020-03-18
- Date posted
- 2020-04-29
- Date terminated
- 2026-02-09
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Surveyor S4 Mobile Monitor (K160685) | Mortara Instrument, Inc. | 2016-08-04 |