Reported Jun 24, 2015 · Terminated
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph.…
Mortara Instrument, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mortara Instrument, Inc · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- 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.
- Lot codes and dates
- Serial NumberSerial Number
69 of 69 codes
114470237158114470237159114470237163114470237169114470237173114470237176114470237191115040243225115040243448115040243449115130250975115130250976115130250977115130250978115130250979115130250980115130250981115130250982115130250983114470237160114470237165114470237172114470237174114470237178114470237179114470237184114470237185114470237188114470237190114470237161114470237162114470237168114470237177114470237183114470237186114470237187115040243087115140252395115140252396115150252749115160253501114470237164114470237167114470237171114470237175115040243229115070245110114470237166114470237170114470237180114470237181114470237182114470237189114370228740115110250032115110250033115110250034114110201576114110201578115140252393
107 of 107 codes
115170254254114530241364115160253238114530241295115070245550115070245551115100247989115100247990115190255287115030241850114500239441115100247699114510240312114510240313115020241387115030241876115040243081114490238052114490238053114490238054114490238055114490238056114490238057114490238058114490238066114510240310115030241851115030241852115030241853115030241854115030241855115030241856115030241857115030241858115030241859115030241860115030241861115030241862115030241863115030241864115030241865115040243079115040243080115060244254115060244255115060244256115060244257115060244258115160253181115160253182115160253183115190255734115190255735115160254106114510240309114490238556114490238557114490238558114490238559114490238560
- Serial Number
- Amount recalled
- 176
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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