Recall Z-2388-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Edan Diagnostics
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The
| Date | Jun 23, 2016 |
| Status | Terminated |
| Reason | Incorrect CO2 readings with some patient monitors. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, EDAN, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated 6/23/2016 via email to its customers on 06/23/16. The letter described the product, problem and actions to be taken. Customers were provided two possible solutions. 1. Re-calibrate the affected monitors: a. The customer needs to source the Calibration Gas and other tools locally, EDAN will provide the Specifications of the Calibration Gas; b. EDAN will provide Calibration Instructions to the customer; c. The customer need to calibrate the monitors by themselves and send the Calibration Record back to EDAN. 2. Replace the |
| Quantity | 521 |
| Distribution | Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, P |
| FDA record | Open on fda.gov |