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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device disinfector, medical devices
Regulation Description Medical washer-disinfector.
Product CodeMEC
Regulation Number 880.6992
Device Class 2

MDR Year MDR Reports MDR Events
2021 93 93
2022 85 86
2023 79 79
2024 78 78
2025 77 77
2026 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 55 55
Leak/Splash 48 48
Device Fell 38 38
Use of Device Problem 36 37
Insufficient Information 33 33
Fire 29 29
Smoking 26 26
Mechanical Jam 23 23
Improper or Incorrect Procedure or Method 23 23
Fluid/Blood Leak 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Problem with Software Installation 14 14
Device Emits Odor 12 12
Mechanical Problem 11 11
Device Handling Problem 11 11
Sharp Edges 10 10
Device Dislodged or Dislocated 9 9
Failure to Disinfect 8 8
Overheating of Device 8 8
Sparking 7 7
Unintended Electrical Shock 6 6
No Apparent Adverse Event 6 6
Installation-Related Problem 6 6
Break 4 4
Fracture 4 4
Unintended Movement 4 4
Failure to Pump 4 4
Application Program Problem 3 3
Unintended System Motion 3 3
Melted 3 3
Failure to Clean Adequately 3 3
No Flow 2 2
Electrical /Electronic Property Problem 2 2
Contamination /Decontamination Problem 2 2
Suction Failure 2 2
Device Alarm System 2 2
Device Tipped Over 2 2
Material Split, Cut or Torn 2 2
Material Twisted/Bent 1 1
Device Difficult to Maintain 1 1
Infusion or Flow Problem 1 1
Gas/Air Leak 1 1
Shipping Damage or Problem 1 1
Misassembly During Maintenance/Repair 1 1
Misassembled During Installation 1 1
Positioning Problem 1 1
Residue After Decontamination 1 1
Tear, Rip or Hole in Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 245 246
Laceration(s) 37 37
Insufficient Information 36 36
Pain 29 29
Bruise/Contusion 29 29
Abrasion 12 12
Muscle/Tendon Damage 12 12
Fall 10 10
Cough 10 10
Sore Throat 10 10
Eye Pain 10 10
Skin Tears 8 8
Bone Fracture(s) 6 6
Burn(s) 5 5
Electric Shock 4 4
Unspecified Tissue Injury 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Musculoskeletal problem 3 3
Partial thickness (Second Degree) Burn 3 3
Damage to Ligament(s) 2 2
Crushing Injury 2 2
Loss of Range of Motion 2 2
Swelling/ Edema 2 2
Headache 2 2
High Blood Pressure/ Hypertension 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Aspiration/Inhalation 1 1
Inflammation 1 1
Keratitis 1 1
Injury 1 1
Neck Pain 1 1
Concussion 1 1
Ecchymosis 1 1
Tinnitus 1 1
Swollen Lymph Nodes/Glands 1 1
Angioedema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Disinfection Ab II Oct-01-2025
2 Getinge Disinfection Ab II May-05-2025
3 Getinge Group Logistics America, LLC II Feb-16-2021
4 Getinge Usa Sales Inc II Jun-08-2022
5 Getinge Usa Sales Inc II May-13-2022
6 Steris Corporation II Dec-11-2025
7 Steris Corporation II May-17-2023
8 Steris Corporation II Jun-09-2022
9 Steris Corporation II Jan-15-2021
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