| Device Type ID | 2675 |
| Device Name | Disinfector, Medical Devices |
| Regulation Description | Medical Washer-disinfector. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6992 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MEC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2675 |
| Device | Disinfector, Medical Devices |
| Product Code | MEC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Washer-disinfector. |
| CFR Regulation Number | 880.6992 [🔎] |
| Device Problems | |
|---|---|
Device Component Or Accessory | 16 |
Component Falling | 11 |
Device Issue | 7 |
Fluid Leak | 6 |
Insufficient Information | 4 |
Leak / Splash | 4 |
Fire | 4 |
Use Of Device Problem | 4 |
Improper Or Incorrect Procedure Or Method | 3 |
Overheating Of Device | 3 |
Break | 2 |
Human Factors Issue | 2 |
Failure To Pump | 2 |
Residue After Decontamination | 2 |
Contamination / Decontamination Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Frayed | 1 |
Component Missing | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Device Operates Differently Than Expected | 1 |
Installation-Related Problem | 1 |
Device Handling Problem | 1 |
Inadequate Or Insufficient Training | 1 |
Detachment Of Device Component | 1 |
Torn Material | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
| Total Device Problems | 86 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Getinge Disinfection Ab | II | Apr-16-2018 |
| 2 | Getinge Disinfection Ab | III | Aug-25-2015 |
| 3 | Getinge Disinfection Ab | II | Dec-23-2014 |
| 4 | Natus Medical Incorporated | II | Jun-02-2017 |
| 5 | Steris Corporation | II | Mar-09-2019 |
| 6 | Steris Corporation | II | Jul-09-2018 |
| 7 | Steris Corporation | III | Jul-10-2014 |