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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device walker, mechanical
Regulation Description Mechanical walker.
Product CodeITJ
Regulation Number 890.3825
Device Class 1

Device Problems
Break 198
Unstable 149
Adverse Event Without Identified Device or Use Problem 63
Bent 42
Collapse 36
Detachment Of Device Component 32
Product Quality Problem 31
Fracture 24
Detachment of Device or Device Component 21
Crack 21
Unintended Movement 19
Use of Device Problem 19
Solder Joint Fracture 19
Material Fragmentation 18
Material Integrity Problem 14
Wheel 11
Device Inoperable 10
Brake 8
Device Slipped 7
Material Separation 7
Device Operates Differently Than Expected 7
Insufficient Information 6
Mechanical Problem 6
Material Twisted/Bent 6
Improper or Incorrect Procedure or Method 6
Naturally Worn 6
Device Tipped Over 5
Device Issue 4
Frame 4
Out-Of-Box Failure 4
Caster 4
Bolus mechanism failure 4
Device Component Or Accessory 3
Device Damaged Prior to Use 3
Mechanical Jam 3
Deformation Due to Compressive Stress 3
Physical Property Issue 2
Device Dislodged or Dislocated 2
Material Deformation 2
Device Handling Problem 2
Structural Problem 2
Device Maintenance Issue 2
Device Unsafe to Use in Environment 2
Mechanics Altered 1
Device Misassembled During Manufacturing /Shipping 1
Device Operational Issue 1
Appropriate Term/Code Not Available 1
Sharp Edges 1
Loose or Intermittent Connection 1
Component Missing 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Material Distortion 1
Material Protrusion/Extrusion 1
Patient-Device Incompatibility 1
Defective Component 1
Labelling, Instructions for Use or Training Problem 1
Unintended Collision 1
Off-Label Use 1
Human-Device Interface Problem 1
Manufacturing, Packaging or Shipping Problem 1
Mechanism 1
Thread 1
Misassembly by Users 1
Noise, Audible 1
Patient Device Interaction Problem 1
Accessory Incompatible 1
Material Disintegration 1
Misassembled 1
Missing Value Reason 1
Bolt 1
Weld 1
Defective Device 1
Installation-Related Problem 1
Bearings 1
Inadequate Service 1
Inadequacy of Device Shape and/or Size 1
Barrier 1
Lock 1
Human Factors Issue 1
Locking Mechanism 1
Total Device Problems 874

Recalls
Manufacturer Recall Class Date Posted
1 Nova Ortho-Med Inc II Oct-24-2016
2 R82 A/S II May-04-2020
3 SVS LLC II Nov-20-2018

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