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ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resti...

FDA Device Recall #Z-1796-2015 — Class II — May 29, 2015

Recall Summary

Recall Number Z-1796-2015
Classification Class II — Moderate risk
Date Initiated May 29, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mortara Instrument, Inc
Location Milwaukee, WI
Product Type Devices
Quantity 176

Product Description

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.

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 Pattern

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.

Lot / Code Information

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 115020241385 115030242164 115120250688 115130250965 115130250966 115130250967 115130250968 114110201950 114110201952 114530241293 114530241294 114530241296 115020241383 115080245620 115110249768 115110249769 115110249770 115110249771 115110249772 115060244864 115160253239 114510240311 115020241384 115020241386 114510240314

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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