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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
CANON MEDICAL SYSTEMS CORPORATION
  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
2018 36 36
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 38 38
Use of Device Problem 30 30
Unintended Movement 20 20
Detachment of Device or Device Component 12 12
No Display/Image 11 11
Mechanical Problem 11 11
Poor Quality Image 10 10
Display or Visual Feedback Problem 8 8
Unintended System Motion 7 7
Output Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Fell 7 7
Break 6 6
Unintended Collision 5 5
Device Dislodged or Dislocated 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Therapeutic or Diagnostic Output Failure 5 5
Insufficient Information 5 5
Device Displays Incorrect Message 4 4
Defective Component 3 3
Device Operates Differently Than Expected 3 3
Defective Device 3 3
Device Alarm System 3 3
No Device Output 3 3
Failure to Power Up 3 3
Detachment Of Device Component 3 3
Device Handling Problem 3 3
Unexpected Shutdown 3 3
Patient Data Problem 2 2
Radiation Output Failure 2 2
Activation Problem 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Power Problem 2 2
Fire 2 2
Product Quality Problem 2 2
Image Orientation Incorrect 2 2
Difficult or Delayed Activation 2 2
Inappropriate or Unexpected Reset 2 2
Installation-Related Problem 2 2
Material Integrity Problem 2 2
Smoking 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 1 1
Connection Problem 1 1
Data Back-Up Problem 1 1
Loss of Data 1 1
Patient-Device Incompatibility 1 1
Application Program Version or Upgrade Problem 1 1
Material Perforation 1 1
Visual Prompts will not Clear 1 1
High Sensing Threshold 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Flare or Flash 1 1
Device Sensing Problem 1 1
Imprecision 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Moisture Damage 1 1
Device Emits Odor 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Inadequate Service 1 1
Device Slipped 1 1
Overheating of Device 1 1
Loss of Power 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Application Program Problem: Dose Calculation Error 1 1
Electrical /Electronic Property Problem 1 1
Component Falling 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Protective Measures Problem 1 1
Operating System Becomes Nonfunctional 1 1
Activation Failure 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Appropriate Term/Code Not Available 1 1
No Apparent Adverse Event 1 1
Misassembled During Installation 1 1
Intermittent Communication Failure 1 1
Intermittent Energy Output 1 1
Radiation Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Known Impact Or Consequence To Patient 41 41
No Consequences Or Impact To Patient 23 23
Radiation Exposure, Unintended 20 20
Insufficient Information 13 13
No Patient Involvement 10 10
No Information 7 7
Pain 6 6
Fall 5 5
Injury 5 5
Patient Problem/Medical Problem 3 3
Suture Abrasion 2 2
No Code Available 2 2
Unintended Radiation Exposure 2 2
Full thickness (Third Degree) Burn 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
Overdose 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Paralysis 1 1
Seroma 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 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
Exsanguination 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Muscle/Tendon Damage 1 1
Abdominal Cramps 1 1
Arthralgia 1 1
Sore Throat 1 1
Sweating 1 1
Post Operative Wound Infection 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 Philips Electronics North America Corporation II Jan-10-2018
6 Philips Healthcare II Nov-24-2021
7 Philips Medical Systems DMC GmbH II Jul-12-2022
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 II May-15-2023
18 Philips North America Llc II Nov-08-2023
19 Philips North America Llc II Apr-10-2023
20 Philips North America Llc II Nov-09-2021
21 Shimadzu Medical Systems II Apr-07-2022
22 Siemens Medical Solutions USA, Inc II Jan-20-2023
23 Siemens Medical Solutions USA, Inc II Oct-21-2022
24 Siemens Medical Solutions USA, Inc II Jun-27-2022
25 Siemens Medical Solutions USA, Inc II Jan-08-2021
26 Siemens Medical Solutions USA, Inc II Aug-05-2020
27 Siemens Medical Solutions USA, Inc II Mar-07-2019
28 Siemens Medical Solutions USA, Inc II Jul-20-2018
29 Siemens Medical Solutions USA, Inc II Mar-20-2018
30 Toshiba American Medical Systems Inc II Mar-02-2018
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