| Device Type ID | 2856 |
| Device Name | Medical Computers And Software |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LNX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2856 |
| Device | Medical Computers And Software |
| Product Code | LNX |
| Device Problems | |
|---|---|
Computer Software Problem | 15 |
Programming Issue | 11 |
Data Problem | 3 |
Device Issue | 3 |
Application Program Problem | 3 |
Application Program Problem: Medication Error | 3 |
Installation-Related Problem | 2 |
Patient Data Problem | 2 |
Alarm Not Visible | 1 |
Failure To Back-Up | 1 |
Device Alarm System | 1 |
Insufficient Information | 1 |
Data Back-Up Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 48 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sorin Group Italia S.r.l. | II | Jan-22-2014 |