ELI 380 Electrocardiograph
Medical device recall Z-1796-2015. Published in FDA’s Enforcement Report on Jun 24, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 24, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 11 states named in where it went
- 176 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
176, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 114470237158 114470237159 114470237163 114470237169 114470237173 114470237176 114470237191 115040243225 115040243448 115040243449 115130250975 115130250976 115130250977 115130250978 115130250979 115130250980 115130250981…
Every code shown here, 1,991 characters
Serial Number 114470237158 114470237159 114470237163 114470237169 114470237173 114470237176 114470237191 115040243225 115040243448 115040243449 115130250975 115130250976 115130250977 115130250978 115130250979 115130250980 115130250981 115130250982 115130250983 114470237160 114470237165 114470237172 114470237174 114470237178 114470237179 114470237184 114470237185 114470237188 114470237190 114470237161 114470237162 114470237168 114470237177 114470237183 114470237186 114470237187 115040243087 115140252395 115140252396 115150252749 115160253501 114470237164 114470237167 114470237171 114470237175 115040243229 115070245110 114470237166 114470237170 114470237180 114470237181 114470237182 114470237189 114370228740 115110250032 115110250033 115110250034 114110201576 114110201578 115140252393 115140252394 115140252399 115140252397 114360227784 115190256009 115190256010 115190256011 115140252400 115150252442 Serial Number 115170254254 114530241364 115160253238 114530241295 115070245550 115070245551 115100247989 115100247990 115190255287 115030241850 114500239441 115100247699 114510240312 114510240313 115020241387 115030241876 115040243081 114490238052 114490238053 114490238054 114490238055 114490238056 114490238057 114490238058 114490238066 114510240310 115030241851 115030241852 115030241853 115030241854 115030241855 115030241856 115030241857 115030241858 115030241859 115030241860 115030241861 115030241862 115030241863 115030241864 115030241865 115040243079 115040243080 115060244254 115060244255 115060244256 115060244257 115060244258 115160253181 115160253182 115160253183 115190255734 115190255735 115160254106 114510240309 114490238556 114490238557 114490238558 114490238559 114490238560 114490238561 115060244381 115060244382 115060244383 115060244384 115060244385 115140252387 115140252388 115140252389 115040243082 115040243085 115040243086 115120250253 115120250254 115120250255 115120250256 115170254250 115170254251 115170254252 115170254253 114360227772 114360227773…
FDA’s list runs to 2,315 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA and WI., and to the countries of : CHINA, PORTUGAL, CANADA, OMAN, MALAYSIA, NEW ZEALAND, INDIA, POLAND, LEBANON, SWITZERLAND, FINLAND, ROMANIA,UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, THE NETHERLANDS, ITALY, FRANCE, GERMANY, THAILAND,SAUDI, ARABIA, NORWAY and IRELAND.
The states and territories these words name
- Arizona
- California
- Florida
- Georgia
- Illinois
- Michigan
- Nebraska
- South Carolina
- Utah
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 29, 2015.
- FDA classified it on Jun 12, 2015.
- FDA’s Enforcement Report published it on Jun 24, 2015.
- FDA terminated it on Aug 5, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Mortara Instrument, Inc, of Milwaukee, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,315 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.