Z-1815-2020Class II

S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP...

Name: Z-1815-2020 S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP...
Creator: Welch Allyn, Inc/mortara
Published: 2020-03-18
License: https://open.fda.gov/license/

Mortara Instrument, Inc. / initiated 2020-03-18 / Terminated / root cause: design

FDA source

WELCH ALLYN, INC/MORTARA began a recall of 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... on 2020-03-18. FDA classified it as Class II and gives the reason as "Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1815-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-18
Posted: 2020-04-29
Terminated: 2026-02-09
Recalling firm: Mortara Instrument, Inc.
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.
Product code: DPS Electrocardiograph
Reason for recall: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1810-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1811-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1812-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1813-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1814-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1815-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1816-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1817-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1818-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29
Z-1819-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code DPS

K160685Class IISurveyor S4 Mobile MonitorMortara Instrument, Inc. / cleared 2016-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)