Recall Z-1796-2015 ยท DPS Electrocardiograph
Mortara Instrument, Inc
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
| Date | Jun 12, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Mortara Instrument, Inc. sent an "Urgent Medical Device Correction" letter dated May 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised that users in their facilities be made aware of the safety notification and that required actions listed on the letter be taken immediately. A Field service Engineer will be dispatched to their facility to update the affected unit(s) on-site. For questions they can contact Technical support at 1-888-667-8272 or Techsupport@mortara.com or contact your lo |
| Quantity | 176 |
| 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 NETHE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142105 | ELI 380 ELECTROCARDIOGRAPH Mortara Instrument, Inc., Sep 5, 2014 |