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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
APELEM-DMS GROUP
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAVIG GMBH
  SUBSTANTIALLY EQUIVALENT 2
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 1
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STEPHANIX RADIOLOGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2922 2922
2016 30 30
2017 34 34
2018 36 36
2019 49 49
2020 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Operating System Problem 788 788
Failure to Power Up 542 542
Device Displays Incorrect Message 457 457
Device Inoperable 377 377
Device Stops Intermittently 372 372
Device Operates Differently Than Expected 210 210
Application Interface Becomes Non-Functional Or Program Exits Abnormally 177 177
Loss of Power 122 122
Patient Data Problem 106 106
Loss of Data 82 82
Communication or Transmission Problem 56 56
Self-Activation or Keying 35 35
Use of Device Problem 33 33
Data Problem 29 29
Mechanical Jam 27 27
No Display/Image 26 26
Break 25 25
Mechanical Problem 24 24
Mechanics Altered 23 23
Detachment of Device or Device Component 18 18
Difficult or Delayed Activation 17 17
Computer Software Problem 17 17
Unintended Movement 17 17
Operating System Becomes Nonfunctional 16 16
Poor Quality Image 15 15
Sticking 14 14
Connection Problem 14 14
Loose or Intermittent Connection 14 14
Handpiece 14 14
Intermittent Continuity 13 13
Detachment Of Device Component 13 13
Power Problem 13 13
Noise, Audible 13 13
Failure to Back-Up 12 12
Component Falling 11 11
Device Operational Issue 11 11
Failure to Shut Off 9 9
No Device Output 9 9
Electrical /Electronic Property Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Data Back-Up Problem 9 9
Image Display Error/Artifact 8 8
Output Problem 8 8
Display or Visual Feedback Problem 7 7
Monitor 7 7
Unintended System Motion 7 7
Collimator 6 6
Disconnection 6 6
Switch, Push Button 6 6
Insufficient Information 6 6
Difficult to Remove 6 6
Failure to Sense 5 5
Device Alarm System 5 5
Unintended Collision 5 5
Radiation Overexposure 5 5
Improper Device Output 4 4
Improper or Incorrect Procedure or Method 4 4
Image Orientation Incorrect 4 4
Device Fell 4 4
Device Subassembly 3 3
Cover 3 3
Screen 3 3
Defective Component 3 3
Inappropriate or Unexpected Reset 3 3
Battery Problem 3 3
Charging Problem 3 3
Overheating of Device 3 3
Device Emits Odor 3 3
Crack 3 3
Defective Device 3 3
Blocked Connection 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Component Or Accessory 3 3
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Open or Close 2 2
Device Dislodged or Dislocated 2 2
Fire 2 2
Power Switch 2 2
Cable, Electrical 2 2
Screw 2 2
Material Protrusion/Extrusion 2 2
Arcing 2 2
Electrical Shorting 2 2
Reset Problem 2 2
Positioning Problem 2 2
Failure to Read Input Signal 2 2
Unstable 2 2
Calibration Error 2 2
Foot Pedal 2 2
Connector 2 2
Erratic or Intermittent Display 2 2
Application Program Problem: Dose Calculation Error 1 1
Display Difficult to Read 1 1
Insufficient Cooling 1 1
Decoupling 1 1
Material Discolored 1 1
Image Resolution Poor 1 1
Difficult to Insert 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2724 2724
No Information 630 630
No Consequences Or Impact To Patient 279 279
Radiation Exposure, Unintended 18 18
No Patient Involvement 14 14
Fall 13 13
Injury 9 9
No Code Available 7 7
Bone Fracture(s) 7 7
Pain 7 7
Laceration(s) 4 4
Suture Abrasion 3 3
Headache 3 3
Patient Problem/Medical Problem 3 3
Complaint, Ill-Defined 2 2
Post Operative Wound Infection 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Nausea 1 1
Overdose 1 1
Hair Loss 1 1
Head Injury 1 1
Radiation Overdose 1 1
Bruise/Contusion 1 1
Contusion 1 1
Death 1 1
Pneumothorax 1 1
Seizures 1 1
Seroma 1 1
Tissue Damage 1 1
Vomiting 1 1
Stenosis 1 1
Anxiety 1 1
Fever 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Physical Entrapment 1 1
Sweating 1 1
Abdominal Cramps 1 1
Pregnancy 1 1
Abrasion 1 1
Burn(s) 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 II Jul-20-2015
4 GE Healthcare II Jul-02-2015
5 GE Healthcare, LLC II Jun-10-2019
6 GE Healthcare, LLC II Dec-23-2016
7 Hans Pausch Rontgengeratebau Gmbh II May-30-2017
8 Philips Electronics North America Corporation II Jan-10-2018
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 Shimadzu Medical Systems II Dec-23-2016
18 Shimadzu Medical Systems II Nov-09-2015
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 Siemens Medical Solutions USA, Inc II Mar-31-2016
24 Siemens Medical Solutions USA, Inc II May-23-2015
25 Toshiba American Medical Systems Inc II Mar-02-2018
26 Toshiba American Medical Systems Inc II Oct-17-2017
27 Toshiba American Medical Systems Inc II Mar-14-2017
28 Toshiba American Medical Systems Inc II Mar-21-2016
29 Ziehm Imaging Inc II Aug-25-2016
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