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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
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
DORNIER MEDTECH AMERICA, INC
  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 35 35
2022 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 34 34
Device Operational Issue 29 29
Unintended Movement 20 20
Device Operates Differently Than Expected 13 13
Detachment of Device or Device Component 11 11
Mechanical Problem 11 11
Poor Quality Image 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Unintended System Motion 7 7
Break 7 7
No Display/Image 7 7
Insufficient Information 6 6
Therapeutic or Diagnostic Output Failure 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Unintended Collision 5 5
Device Displays Incorrect Message 5 5
Device Dislodged or Dislocated 5 5
Output Problem 5 5
Display or Visual Feedback Problem 4 4
Detachment Of Device Component 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
Defective Component 2 2
Defective Device 2 2
Smoking 2 2
Unstable 2 2
Positioning Problem 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Improper Device Output 2 2
Installation-Related Problem 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
Intermittent Communication Failure 1 1
Activation Problem 1 1
Operating System Becomes Nonfunctional 1 1
Appropriate Term/Code Not Available 1 1
No Apparent Adverse Event 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
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Rupture 1 1
Inadequate Service 1 1
Device Slipped 1 1
Output above Specifications 1 1
Device Emits Odor 1 1
Misassembled 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
Mechanics Altered 1 1
Power Problem 1 1
Radiation Overexposure 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

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 47 47
No Consequences Or Impact To Patient 26 26
Radiation Exposure, Unintended 22 22
No Patient Involvement 10 10
No Information 10 10
Injury 8 8
Fall 6 6
Pain 6 6
Insufficient Information 5 5
No Code Available 4 4
Laceration(s) 4 4
Bone Fracture(s) 4 4
Suture Abrasion 3 3
Patient Problem/Medical Problem 3 3
Complaint, Ill-Defined 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 DMC GmbH II Jul-12-2022
9 Philips Medical Systems Gmbh, DMC II Aug-28-2021
10 Philips Medical Systems Gmbh, DMC II Feb-20-2020
11 Philips Medical Systems Gmbh, DMC II Feb-12-2019
12 Philips Medical Systems Nederlands II Jun-27-2018
13 Philips North America, LLC II Jul-10-2020
14 Philips North America, LLC II Jun-03-2020
15 Philips North America, LLC II Apr-24-2020
16 Philips North America, LLC II Apr-11-2019
17 Philips North America, LLC II Mar-23-2019
18 Philips North America Llc II Nov-09-2021
19 Shimadzu Medical Systems II Apr-07-2022
20 Siemens Medical Solutions USA, Inc II Jun-27-2022
21 Siemens Medical Solutions USA, Inc II Jan-08-2021
22 Siemens Medical Solutions USA, Inc II Aug-05-2020
23 Siemens Medical Solutions USA, Inc II Mar-07-2019
24 Siemens Medical Solutions USA, Inc II Jul-20-2018
25 Siemens Medical Solutions USA, Inc II Mar-20-2018
26 Toshiba American Medical Systems Inc II Mar-02-2018
27 Toshiba American Medical Systems Inc II Oct-17-2017
28 Toshiba American Medical Systems Inc II Mar-14-2017
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