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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accelerator, linear, medical
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
AKTINA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 5
C-RAD POSITIONING AB
  SUBSTANTIALLY EQUIVALENT 2
CARBON MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CNMC CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 2
ELECKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 4
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 2
ELEKTA, INC
  SUBSTANTIALLY EQUIVALENT 1
ESSEBI MEDICAL SRL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 2
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAP
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MICROPOS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
NASLUND MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 2
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
POLL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 2
QFIX
  SUBSTANTIALLY EQUIVALENT 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADIALOGICA LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIATION PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTSAFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 5
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 4
ZAP SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 85 85
2019 91 91
2020 74 74
2021 69 69
2022 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 177 177
Use of Device Problem 27 27
Detachment of Device or Device Component 17 17
Fluid/Blood Leak 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Break 9 9
No Apparent Adverse Event 9 9
Mechanical Problem 8 8
Unintended Movement 8 8
Data Problem 8 8
Communication or Transmission Problem 8 8
Application Program Problem 7 7
Unintended Collision 7 7
Improper or Incorrect Procedure or Method 7 7
Loss of Data 7 7
Application Program Problem: Dose Calculation Error 7 7
Unintended System Motion 7 7
Material Deformation 6 6
Compatibility Problem 5 5
Unstable 5 5
Use of Incorrect Control/Treatment Settings 5 5
Device Operates Differently Than Expected 4 4
Device Handling Problem 4 4
Insufficient Information 4 4
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Electrical /Electronic Property Problem 3 3
Loose or Intermittent Connection 3 3
Human-Device Interface Problem 3 3
Installation-Related Problem 3 3
Device Fell 3 3
Defective Component 3 3
Material Integrity Problem 3 3
Radiation Overexposure 3 3
Product Quality Problem 2 2
Therapy Delivered to Incorrect Body Area 2 2
Inadequate or Insufficient Training 2 2
Application Network Problem 2 2
Program or Algorithm Execution Problem 2 2
Component Misassembled 2 2
Positioning Problem 2 2
Connection Problem 2 2
Image Orientation Incorrect 2 2
Disconnection 2 2
Component Falling 2 2
Display or Visual Feedback Problem 2 2
Activation, Positioning or Separation Problem 2 2
Inadequate User Interface 2 2
Retraction Problem 2 2
Material Too Soft/Flexible 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Inadequate Lubrication 1 1
Device Slipped 1 1
Smoking 1 1
Device Dislodged or Dislocated 1 1
Temperature Problem 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Deflation Problem 1 1
Degraded 1 1
No Display/Image 1 1
Material Puncture/Hole 1 1
Failure to Recalibrate 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Microbial Contamination of Device 1 1
Inaccurate Delivery 1 1
Calibration Problem 1 1
Thermal Decomposition of Device 1 1
Self-Activation or Keying 1 1
Malposition of Device 1 1
Improper Chemical Reaction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Radiation Underexposure 1 1
Misassembly During Maintenance/Repair 1 1
Application Security Problem 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Device Operational Issue 1 1
Human Factors Issue 1 1
Computer Operating System Problem 1 1
Computer System Security Problem 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Application Program Problem: Parameter Calculation Error 1 1
Detachment Of Device Component 1 1
Decoupling 1 1
Misconnection 1 1
Reset Problem 1 1
Unexpected/Unintended Radiation Output 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
No Known Impact Or Consequence To Patient 89 89
Insufficient Information 85 85
No Information 63 63
No Consequences Or Impact To Patient 58 58
No Patient Involvement 37 37
Radiation Overdose 15 15
Unintended Radiation Exposure 9 9
Bone Fracture(s) 4 4
Inflammation 3 3
Radiation Underdose 3 3
Pain 3 3
Injury 2 2
Headache 2 2
Incontinence 2 2
Limb Fracture 2 2
Neuropathy 2 2
Abrasion 2 2
Radiation Burn 2 2
Burn(s) 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Not Applicable 1 1
Bruise/Contusion 1 1
Death 1 1
Constipation 1 1
Necrosis 1 1
Blurred Vision 1 1
Hot Flashes/Flushes 1 1
Tingling 1 1
Brain Injury 1 1
Radiodermatitis 1 1
Non-union Bone Fracture 1 1
Irritability 1 1
Confusion/ Disorientation 1 1
Fall 1 1
Chills 1 1
Urinary Frequency 1 1
Swelling 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Neck Pain 1 1
Sweating 1 1
Ambulation Difficulties 1 1
Fatigue 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Radiation Exposure, Unintended 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Diarrhea 1 1
Fistula 1 1
Head Injury 1 1
Depression 1 1
Reaction 1 1
Suture Abrasion 1 1
Weakness 1 1
Burning Sensation 1 1
Dizziness 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Mar-17-2021
2 Accuray Incorporated II Jan-07-2021
3 Accuray Incorporated II Jun-01-2019
4 Accuray Incorporated II Nov-08-2018
5 Accuray Incorporated II Sep-20-2018
6 Brainlab AG II Mar-08-2022
7 Brainlab AG II Jun-10-2021
8 Brainlab AG II Mar-08-2021
9 Brainlab AG II Mar-14-2018
10 C-RAD POSITIONING AB II Jul-14-2021
11 ELEKTA SOLUTIONS AB II Oct-14-2021
12 Elekta Limited II Jun-08-2020
13 Elekta Limited II May-08-2019
14 Elekta Limited II Apr-08-2019
15 Elekta Limited II Jan-09-2019
16 Elekta Limited II Feb-26-2018
17 Elekta, Inc. II Oct-14-2021
18 Elekta, Inc. II Sep-29-2021
19 Elekta, Inc. II Jun-02-2021
20 Elekta, Inc. II Jun-30-2020
21 Elekta, Inc. II Jun-05-2020
22 Elekta, Inc. II Aug-09-2019
23 Elekta, Inc. II Jul-16-2019
24 Elekta, Inc. II Feb-08-2019
25 Elekta, Inc. II Dec-27-2018
26 Elekta, Inc. II Aug-23-2018
27 Elekta, Inc. II Aug-17-2018
28 Hitachi Ltd., Medical System Operations Group II May-01-2018
29 Klarity Medical Products LLC II Aug-24-2020
30 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
31 Med Tec Inc II Jun-02-2020
32 Med Tec Inc II Jun-18-2019
33 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
34 PTW NORTH AMERICA CORPORATION II Jan-11-2022
35 Reflexion Medical, Inc. II Jan-10-2022
36 Siemens Medical Solutions USA, Inc II Dec-09-2022
37 Siemens Medical Solutions USA, Inc II Dec-29-2021
38 Siemens Medical Solutions USA, Inc II Apr-07-2020
39 Siemens Medical Solutions USA, Inc II Feb-21-2020
40 Siemens Medical Solutions USA, Inc II Aug-06-2019
41 Siemens Medical Solutions USA, Inc II Apr-19-2019
42 Siemens Medical Solutions USA, Inc II Apr-17-2018
43 Varian Medical Systems II Oct-01-2018
44 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
45 Varian Medical Systems, Inc. II May-05-2020
46 Viewray, Inc. II Nov-20-2020
47 Viewray, Inc. II Apr-27-2020
48 Viewray, Inc. II Dec-12-2019
49 Viewray, Inc. II May-02-2019
50 Vision RT Ltd II Oct-03-2018
51 Zap Surgical Systems II Sep-14-2022
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