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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 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
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING LLC
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 25 25
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 39 39
Use of Device Problem 29 29
Unintended Movement 22 22
Detachment of Device or Device Component 19 19
Mechanical Problem 12 12
Device Fell 10 10
Display or Visual Feedback Problem 9 9
No Display/Image 9 9
Unintended System Motion 9 9
Poor Quality Image 8 8
Break 7 7
Unintended Collision 6 6
Output Problem 6 6
Device Handling Problem 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Device Dislodged or Dislocated 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Insufficient Information 4 4
Radiation Output Failure 4 4
Unexpected Shutdown 3 3
Smoking 3 3
Defective Component 3 3
No Device Output 2 2
Improper or Incorrect Procedure or Method 2 2
Electrical /Electronic Property Problem 2 2
Inappropriate or Unexpected Reset 2 2
Image Orientation Incorrect 2 2
Product Quality Problem 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Activation 2 2
Failure to Power Up 2 2
Patient Data Problem 2 2
Positioning Problem 2 2
Material Integrity Problem 2 2
Defective Device 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Device Alarm System 2 2
Activation Problem 2 2
Device Slipped 1 1
Unstable 1 1
Fluid/Blood Leak 1 1
Intermittent Communication Failure 1 1
Mechanical Jam 1 1
Loss of Data 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Operating System Becomes Nonfunctional 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 116 116
No Known Impact Or Consequence To Patient 28 28
No Consequences Or Impact To Patient 17 17
Radiation Exposure, Unintended 15 15
Insufficient Information 15 15
No Patient Involvement 7 7
No Information 4 4
Pain 4 4
Patient Problem/Medical Problem 3 3
Injury 3 3
Laceration(s) 3 3
No Code Available 2 2
Bone Fracture(s) 2 2
Full thickness (Third Degree) Burn 2 2
Unintended Radiation Exposure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Vascular Dissection 1 1
Exsanguination 1 1
Abrasion 1 1
Suture Abrasion 1 1
Contusion 1 1
Overdose 1 1
Post Operative Wound Infection 1 1
Paralysis 1 1
Seroma 1 1
Discomfort 1 1
Fall 1 1
Muscle/Tendon Damage 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Therapeutic Effects, Unexpected 1 1
Sore Throat 1 1
Thrombus 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Aug-27-2024
2 Agfa N.V. II Jun-03-2020
3 Agfa N.V. II Jul-30-2019
4 GE Healthcare, LLC II Feb-09-2021
5 GE Healthcare, LLC II Jun-10-2019
6 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
7 Philips Healthcare II Nov-24-2021
8 Philips Medical Systems DMC GmbH II Nov-07-2025
9 Philips Medical Systems DMC GmbH II Jul-12-2022
10 Philips Medical Systems Gmbh, DMC II Aug-28-2021
11 Philips Medical Systems Gmbh, DMC II Feb-20-2020
12 Philips Medical Systems Gmbh, DMC II Feb-12-2019
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 II Feb-09-2024
19 Philips North America II May-15-2023
20 Philips North America Llc II Nov-08-2023
21 Philips North America Llc II Apr-10-2023
22 Philips North America Llc II Nov-09-2021
23 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Nov-07-2024
24 Shimadzu Medical Systems II Apr-07-2022
25 Siemens Medical Solutions USA, Inc II Jun-17-2025
26 Siemens Medical Solutions USA, Inc II Jan-20-2023
27 Siemens Medical Solutions USA, Inc II Oct-21-2022
28 Siemens Medical Solutions USA, Inc II Jun-27-2022
29 Siemens Medical Solutions USA, Inc II Jan-08-2021
30 Siemens Medical Solutions USA, Inc II Aug-05-2020
31 Siemens Medical Solutions USA, Inc II Mar-07-2019
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