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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86716

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 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

1 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 1

ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.

Z-0553-2021
Recall number
Z-0553-2021
Initiated
November 11, 2020
Classification
Class II
Status
Terminated
Recalling firm
WELCH ALLYN, INC/MORTARA
Quantity
1,009 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The radio within the device can become disassociated with the wireless access point.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The radio within the device can become disassociated with the wireless access point.

Code information

Part Number Device Identifier ELI380-ABS12 00732094265545 ELI380-ABX12 00732094265514 ELI380-ACQ12 00732094319439 ELI380-ACS11 00812345026313 ELI380-ACX11 00812345024531 ELI380-ACX12 00732094265439 ELI380-ACX21 00812345024562 ELI380-ACX22 00732094265422 ELI380-ACX32 00732094265415 ELI380-DAS44 00732094265354 ELI380-DBX12 00732094265286 ELI380-DBX22 00732094265279 ELI380-DCP12 00732094301670 ELI380-DCQ11 00732094307870 ELI380-DCS11 00812345026917 ELI380-DCS12 00732094265248 ELI380-DCS21 00812345026924 ELI380-DCS43 00812345026948 ELI380-DCT12 00732094265217 ELI380-DCX11 00812345026979 ELI380-DCX12 00732094265200 ELI380-DCX21 00812345026986 ELI380-DCX22 00732094265194 ELI380-DCX32 00732094265187 ELI380-DCX43 00812345027006

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.

Field note

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