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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, surgical with orthopedic accessories, ac-powered
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeJEA
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2020 46 46
2021 40 40
2022 32 32
2023 33 33
2024 36 36
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 37 37
Use of Device Problem 35 35
Insufficient Information 22 22
Adverse Event Without Identified Device or Use Problem 17 17
Device Slipped 13 13
Unexpected Shutdown 13 13
Detachment of Device or Device Component 10 10
Device Fell 9 9
Unintended System Motion 9 9
Improper or Incorrect Procedure or Method 6 6
Device Dislodged or Dislocated 6 6
Positioning Problem 5 5
Mechanical Problem 4 4
Crack 4 4
Positioning Failure 4 4
Fracture 4 4
Material Separation 4 4
Break 3 3
Loss of or Failure to Bond 3 3
Output Problem 3 3
Smoking 3 3
Electrical Shorting 3 3
Device Handling Problem 3 3
Patient-Device Incompatibility 2 2
Corroded 2 2
Overheating of Device 2 2
Patient Device Interaction Problem 2 2
Misassembly by Users 2 2
Noise, Audible 1 1
Unintended Collision 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Electrical /Electronic Property Problem 1 1
Connection Problem 1 1
Intermittent Continuity 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Misconnection 1 1
Use of Incorrect Control/Treatment Settings 1 1
Structural Problem 1 1
Component Missing 1 1
Battery Problem 1 1
Degraded 1 1
Key or Button Unresponsive/not Working 1 1
Moisture Damage 1 1
Therapeutic or Diagnostic Output Failure 1 1
Wireless Communication Problem 1 1
Collapse 1 1
Physical Resistance/Sticking 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90 90
Fall 43 43
Insufficient Information 25 25
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 5 5
Bruise/Contusion 4 4
Pressure Sores 4 4
Laceration(s) 4 4
Unintended Extubation 3 3
Bone Fracture(s) 3 3
Injury 3 3
Numbness 3 3
Necrosis 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Skin Tears 2 2
Swelling/ Edema 2 2
Burn(s) 2 2
Paralysis 2 2
Muscle/Tendon Damage 2 2
Pain 2 2
Ambulation Difficulties 1 1
Vertebral Fracture 1 1
Low Oxygen Saturation 1 1
Respiratory Insufficiency 1 1
Paraplegia 1 1
Extubate 1 1
Bacterial Infection 1 1
Cardiovascular Insufficiency 1 1
Stenosis 1 1
Limb Fracture 1 1
Hyperextension 1 1
No Patient Involvement 1 1
Nerve Damage 1 1
Erythema 1 1
Paresthesia 1 1
Cardiac Arrest 1 1
Blister 1 1
Low Cardiac Output 1 1
Perforation 1 1
Muscle Weakness 1 1
Hematoma 1 1
Head Injury 1 1
No Information 1 1
No Code Available 1 1
Skin Irritation 1 1
Pulmonary Dysfunction 1 1
Arrhythmia 1 1
Damage to Ligament(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-21-2025
2 Baxter Healthcare Corporation II Oct-24-2024
3 Mizuho OSI II Oct-09-2020
4 Steris Corporation II Feb-24-2021
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