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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 2
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 25 25
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 36 36
Detachment of Device or Device Component 18 18
Use of Device Problem 15 15
Unintended Movement 15 15
Mechanical Problem 10 10
Device Fell 7 7
Unintended System Motion 6 6
Display or Visual Feedback Problem 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Unintended Collision 5 5
Break 5 5
Output Problem 5 5
No Display/Image 4 4
Device Handling Problem 4 4
Poor Quality Image 3 3
Unexpected Shutdown 3 3
Device Dislodged or Dislocated 3 3
Product Quality Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Inappropriate or Unexpected Reset 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Defective Device 2 2
Difficult or Delayed Activation 2 2
Patient Data Problem 2 2
Defective Component 2 2
Radiation Output Failure 2 2
Activation Problem 2 2
Radiation Overexposure 1 1
Protective Measures Problem 1 1
Power Problem 1 1
Positioning Problem 1 1
Operating System Becomes Nonfunctional 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Mechanics Altered 1 1
Intermittent Energy Output 1 1
Mechanical Jam 1 1
Radiation Output Problem 1 1
Separation Problem 1 1
Material Deformation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Misassembled During Installation 1 1
Failure to Power Up 1 1
Loss of Power 1 1
No Device Output 1 1
Energy Output Problem 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
Insufficient Information 14 14
Radiation Exposure, Unintended 12 12
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 7 7
No Patient Involvement 3 3
Pain 3 3
Injury 2 2
Full thickness (Third Degree) Burn 2 2
Unintended Radiation Exposure 2 2
Laceration(s) 2 2
Discomfort 1 1
Arthralgia 1 1
Sore Throat 1 1
Vascular Dissection 1 1
No Code Available 1 1
Bruise/Contusion 1 1
Contusion 1 1
Exsanguination 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Paralysis 1 1
Perforation of Vessels 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 GE Healthcare, LLC II Feb-09-2021
4 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
5 Philips Healthcare II Nov-24-2021
6 Philips Medical Systems DMC GmbH II Jul-12-2022
7 Philips Medical Systems Gmbh, DMC II Aug-28-2021
8 Philips Medical Systems Gmbh, DMC II Feb-20-2020
9 Philips North America, LLC II Jul-10-2020
10 Philips North America, LLC II Jun-03-2020
11 Philips North America, LLC II Apr-24-2020
12 Philips North America II Feb-09-2024
13 Philips North America II May-15-2023
14 Philips North America Llc II Nov-08-2023
15 Philips North America Llc II Apr-10-2023
16 Philips North America Llc II Nov-09-2021
17 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Nov-07-2024
18 Shimadzu Medical Systems II Apr-07-2022
19 Siemens Medical Solutions USA, Inc II Jan-20-2023
20 Siemens Medical Solutions USA, Inc II Oct-21-2022
21 Siemens Medical Solutions USA, Inc II Jun-27-2022
22 Siemens Medical Solutions USA, Inc II Jan-08-2021
23 Siemens Medical Solutions USA, Inc II Aug-05-2020
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