ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. A
FDA device recall Z-1796-2015 · posted 2015-06-12 · Terminated
Recall details
- Recalling firm
- Mortara Instrument, Inc
- 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.
- Action taken
- 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 local service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 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, POLAN
- Date initiated
- 2015-05-29
- Date posted
- 2015-06-12
- Date terminated
- 2015-08-05
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELI 380 ELECTROCARDIOGRAPH (K142105) | Mortara Instrument, Inc. | 2014-09-05 |