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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85297

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 18, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
WELCH ALLYN, INC/MORTARA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.

Z-1810-2020
Recall number
Z-1810-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX.

Distribution pattern

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.

device · product 2 of 10

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.

Z-1811-2020
Recall number
Z-1811-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: 11066-XXX-50, 41000-029-XX.

Distribution pattern

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.

device · product 3 of 10

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.

Z-1812-2020
Recall number
Z-1812-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: H12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51.

Distribution pattern

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.

device · product 4 of 10

T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.

Z-1813-2020
Recall number
Z-1813-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.

Distribution pattern

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.

device · product 5 of 10

X12+ and patient cable for the X12+ Telemeter 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, PAT CBL 4WIRE AHA SNAP HC.

Z-1814-2020
Recall number
Z-1814-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50

Distribution pattern

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.

device · product 6 of 10

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.

Z-1815-2020
Recall number
Z-1815-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

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.

Distribution pattern

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.

device · product 7 of 10

Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.

Z-1816-2020
Recall number
Z-1816-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, 9293-033-53.

Distribution pattern

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.

device · product 8 of 10

Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.

Z-1817-2020
Recall number
Z-1817-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: QS-6XX-XXXXX, XSCRIBE-5XX-XXXXX, XSCRIBE-6XX-XXXXX.

Distribution pattern

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.

device · product 9 of 10

Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.

Z-1818-2020
Recall number
Z-1818-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Same as X12+ Model Number X12PLUS-XXX-XXXXX

Distribution pattern

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.

device · product 10 of 10

Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.

Z-1819-2020
Recall number
Z-1819-2020
Initiated
March 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
78,521 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Code information

Model Numbers: 9293-046-60 - 9293-047-71; 9293-017-50 - 9293-017-51; 9293-026-50 - 9293-026-51; 9293-061-50 - 9293-061-53; 9293-033-52 - 9293-033-53 and 9293-034-50.

Distribution pattern

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.