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
Check against the official notice below — it lists the full affected range.
Mortara Instrument, Inc. has recalled 176 units of the ELI 380 electrocardiograph due to a software issue that can cause ECG waveforms from one patient to become associated with the demographic information of a different patient when records are transmitted to a records management system. This hazard occurs only when the device is used in a particular workflow. The affected devices were distributed worldwide, including to multiple U.S. states and countries across Europe, Asia, the Middle East, Australia, and New Zealand.
The specific serial numbers of the affected devices are listed in the recall record. However, the source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 176 Lot/code info: 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 115
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.