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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, fluoroscopic, image-intensified
Regulation Description Image-intensified fluoroscopic x-ray system.
Product CodeJAA
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
APELEM-DMS GROUP
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
GENERAL MEDICAL MERATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 3
PAUSCH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 3
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 34 34
2018 36 36
2019 49 49
2020 39 39
2021 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 33 33
Device Operational Issue 23 23
Unintended Movement 18 18
Device Operates Differently Than Expected 13 13
Poor Quality Image 9 9
Detachment of Device or Device Component 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Mechanical Problem 7 7
No Display/Image 7 7
Break 6 6
Unintended System Motion 6 6
Insufficient Information 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Device Dislodged or Dislocated 5 5
Device Displays Incorrect Message 5 5
Unintended Collision 4 4
Detachment Of Device Component 4 4
Display or Visual Feedback Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Fell 4 4
Device Alarm System 3 3
Failure to Power Up 3 3
Communication or Transmission Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Output Problem 3 3
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Improper Device Output 2 2
Installation-Related Problem 2 2
Defective Component 2 2
Unstable 2 2
Defective Device 2 2
No Device Output 2 2
Overheating of Device 2 2
Image Display Error/Artifact 2 2
Image Orientation Incorrect 2 2
Patient Data Problem 2 2
Device Handling Problem 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Radiation Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Intermittent Communication Failure 1 1
Activation Problem 1 1
Imprecision 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Application Program Problem: Dose Calculation Error 1 1
Entrapment of Device 1 1
Fire 1 1
Fluid Leak 1 1
Material Fragmentation 1 1
Component Falling 1 1
Computer Software Problem 1 1
Insufficient Cooling 1 1
Crack 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Difficult To Position 1 1
Loss of Power 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Rupture 1 1
Inadequate Service 1 1
Device Slipped 1 1
Smoking 1 1
Output above Specifications 1 1
Misassembled 1 1
Device Emits Odor 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Computer Operating System Problem 1 1
Data Back-Up Problem 1 1
Failure to Align 1 1
High Sensing Threshold 1 1
Difficult or Delayed Activation 1 1
Date/Time-Related Software Problem 1 1
Material Perforation 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Deformation 1 1
Inappropriate or Unexpected Reset 1 1
Human Factors Issue 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Positioning Problem 1 1
Power Problem 1 1
Radiation Overexposure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 61 61
No Clinical Signs, Symptoms or Conditions 33 33
No Consequences Or Impact To Patient 26 26
Radiation Exposure, Unintended 21 21
No Patient Involvement 10 10
No Information 10 10
Injury 8 8
Fall 6 6
Pain 6 6
Bone Fracture(s) 4 4
Laceration(s) 4 4
No Code Available 4 4
Patient Problem/Medical Problem 3 3
Suture Abrasion 3 3
Complaint, Ill-Defined 2 2
Insufficient Information 2 2
Muscle/Tendon Damage 1 1
Device Embedded In Tissue or Plaque 1 1
Abdominal Cramps 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Nausea 1 1
Overdose 1 1
Stenosis 1 1
Hair Loss 1 1
Headache 1 1
Fever 1 1
Radiation Overdose 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Contusion 1 1
Death 1 1
Pneumothorax 1 1
Seroma 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Jun-03-2020
2 Agfa N.V. II Jul-30-2019
3 GE Healthcare, LLC II Feb-09-2021
4 GE Healthcare, LLC II Jun-10-2019
5 Hans Pausch Rontgengeratebau Gmbh II May-30-2017
6 Philips Electronics North America Corporation II Jan-10-2018
7 Philips Healthcare II Nov-24-2021
8 Philips Medical Systems Gmbh, DMC II Aug-28-2021
9 Philips Medical Systems Gmbh, DMC II Feb-20-2020
10 Philips Medical Systems Gmbh, DMC II Feb-12-2019
11 Philips Medical Systems Nederlands II Jun-27-2018
12 Philips North America, LLC II Jul-10-2020
13 Philips North America, LLC II Jun-03-2020
14 Philips North America, LLC II Apr-24-2020
15 Philips North America, LLC II Apr-11-2019
16 Philips North America, LLC II Mar-23-2019
17 Philips North America Llc II Nov-09-2021
18 Siemens Medical Solutions USA, Inc II Jan-08-2021
19 Siemens Medical Solutions USA, Inc II Aug-05-2020
20 Siemens Medical Solutions USA, Inc II Mar-07-2019
21 Siemens Medical Solutions USA, Inc II Jul-20-2018
22 Siemens Medical Solutions USA, Inc II Mar-20-2018
23 Toshiba American Medical Systems Inc II Mar-02-2018
24 Toshiba American Medical Systems Inc II Oct-17-2017
25 Toshiba American Medical Systems Inc II Mar-14-2017
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