Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5,...
Reason for Recall / Hazard
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Product Description & Identification
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
Affected Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 97879 |
| Address 1 | 9833 Pacific Heights Blvd |
| Code info | EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001 260342-M16506570001 260342-M15A03180001 002338-K22100150003 002338-K22100150004 002338-K22100150002 002338-K22100150001 261241-M22701020001 002338-M25705810020 002338-M25705810021 002338-M25705810011 002338-M25705810003 002338-M25705810013 002338-M25705810029 002338-M25705810033 002338-M25705810001 002338-M25705810010 002338-M25705810009 002338-M25705810004 002338-M25705810012 002338-M25705810018 002338-M25705810032 002338-M25705810017 002338-M25705810019 002338-M25705810024 002338-M25705810030 002338-M25705810031 002338-M25705810025 002338-M25705810016 002338-M25705810008 002338-M25705810006 002338-M25705810002 002338-M25705810028 002338-M25705810027 002338-M25705810022 002338-M25705810026 002338-M25705810023 002338-M25705810015 002338-M25705810014 002338-M257... [TRUNCATED] |
| Postal code | 92121-4707 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 342 |
| Reason for recall | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251024 |
| Initial firm notification | Letter |
| Center classification date | 20260122 |
Overview
- Recalling FirmEdan Diagnostics
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.