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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 6
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
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
ESSEBI MEDICAL SRL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KALLISIO, INC
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 3
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  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
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
PAPRICALAB
  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
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 2
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 5
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 91 91
2020 74 74
2021 68 68
2022 67 67
2023 128 128
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 233 233
Use of Device Problem 28 28
Detachment of Device or Device Component 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Unintended System Motion 17 17
Fluid/Blood Leak 11 11
Unintended Movement 10 10
Break 9 9
Communication or Transmission Problem 8 8
Application Program Problem 7 7
Unstable 7 7
Application Program Problem: Dose Calculation Error 7 7
Data Problem 7 7
Device Handling Problem 7 7
Mechanical Problem 6 6
Unintended Collision 6 6
Off-Label Use 6 6
Material Deformation 6 6
No Apparent Adverse Event 5 5
Insufficient Information 4 4
Output Problem 4 4
Device Fell 4 4
Therapeutic or Diagnostic Output Failure 4 4
Installation-Related Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Electrical /Electronic Property Problem 4 4
Use of Incorrect Control/Treatment Settings 3 3
Therapy Delivered to Incorrect Body Area 3 3
Labelling, Instructions for Use or Training Problem 3 3
Defective Component 3 3
Inadequate User Interface 3 3
Human-Device Interface Problem 3 3
Material Integrity Problem 3 3
Protective Measures Problem 3 3
Radiation Overexposure 3 3
Intermittent Communication Failure 3 3
Program or Algorithm Execution Problem 2 2
Positioning Problem 2 2
Material Too Soft/Flexible 2 2
Connection Problem 2 2
Loss of Data 2 2
Compatibility Problem 2 2
Low impedance 2 2
Application Network Problem 2 2
Failure to Recalibrate 2 2
Retraction Problem 2 2
Product Quality Problem 2 2
Inadequate or Insufficient Training 2 2
Disconnection 2 2
Display or Visual Feedback Problem 2 2
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Insufficient Cooling 1 1
Crack 1 1
Decoupling 1 1
Degraded 1 1
Fire 1 1
Material Fragmentation 1 1
Image Orientation Incorrect 1 1
Melted 1 1
Misconnection 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Self-Activation or Keying 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Smoking 1 1
Loose or Intermittent Connection 1 1
Loss of or Failure to Bond 1 1
Overheating of Device 1 1
Application Program Problem: Parameter Calculation Error 1 1
Failure to Power Up 1 1
Microbial Contamination of Device 1 1
Inaccurate Delivery 1 1
Failure to Calibrate 1 1
Malposition of Device 1 1
Application Security Problem 1 1
Calibration Problem 1 1
Computer System Security Problem 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Activation, Positioning or Separation Problem 1 1
Improper Chemical Reaction 1 1
Radiation Underexposure 1 1
Reset Problem 1 1
Temperature Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Material Split, Cut or Torn 1 1
Radiation Output Failure 1 1
Unexpected/Unintended Radiation Output 1 1
Excessive Heating 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Component Misassembled 1 1
Incomplete or Inadequate Connection 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 212 212
Insufficient Information 190 190
No Known Impact Or Consequence To Patient 53 53
No Information 44 44
No Consequences Or Impact To Patient 36 36
No Patient Involvement 29 29
Unintended Radiation Exposure 13 13
Bone Fracture(s) 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Limb Fracture 2 2
Radiation Burn 2 2
Abrasion 2 2
Incontinence 2 2
Neuropathy 2 2
Laceration(s) 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Radiation Overdose 1 1
Radiation Exposure, Unintended 1 1
Not Applicable 1 1
Cancer 1 1
Constipation 1 1
Necrosis 1 1
Nerve Damage 1 1
Foreign Body In Patient 1 1
Brain Injury 1 1
Radiodermatitis 1 1
Ulcer 1 1
Injury 1 1
Neck Pain 1 1
Ambulation Difficulties 1 1
Pain 1 1
Radiation Underdose 1 1
Dysphasia 1 1
Inflammation 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Crushing Injury 1 1
Fall 1 1
Head Injury 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Aug-31-2023
2 Accuray Incorporated II Mar-17-2021
3 Accuray Incorporated II Jan-07-2021
4 Accuray Incorporated II Jun-01-2019
5 Brainlab AG II Mar-16-2023
6 Brainlab AG II Mar-08-2022
7 Brainlab AG II Jun-10-2021
8 Brainlab AG II Mar-08-2021
9 C-RAD POSITIONING AB II Jul-14-2021
10 ELEKTA SOLUTIONS AB II Oct-14-2021
11 Elekta Limited II Jun-08-2020
12 Elekta Limited II May-08-2019
13 Elekta Limited II Apr-08-2019
14 Elekta Limited II Jan-09-2019
15 Elekta, Inc. II Dec-01-2023
16 Elekta, Inc. II Jun-02-2023
17 Elekta, Inc. II May-30-2023
18 Elekta, Inc. II Oct-14-2021
19 Elekta, Inc. II Sep-29-2021
20 Elekta, Inc. II Jun-02-2021
21 Elekta, Inc. II Jun-30-2020
22 Elekta, Inc. II Jun-05-2020
23 Elekta, Inc. II Aug-09-2019
24 Elekta, Inc. II Jul-16-2019
25 Elekta, Inc. II Feb-08-2019
26 Klarity Medical Products LLC II Aug-24-2020
27 Landauer II Dec-22-2023
28 Landauer II Sep-12-2023
29 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
30 Med Tec Inc II Jun-02-2020
31 Med Tec Inc II Jun-18-2019
32 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
33 PTW NORTH AMERICA CORPORATION II Jan-11-2022
34 PTW-FREIBURG II Feb-22-2024
35 PTW-FREIBURG II Sep-11-2023
36 Reflexion Medical, Inc. II Jan-10-2022
37 Siemens Medical Solutions USA, Inc II Dec-09-2022
38 Siemens Medical Solutions USA, Inc II Dec-29-2021
39 Siemens Medical Solutions USA, Inc II Apr-07-2020
40 Siemens Medical Solutions USA, Inc II Feb-21-2020
41 Siemens Medical Solutions USA, Inc II Aug-06-2019
42 Siemens Medical Solutions USA, Inc II Apr-19-2019
43 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
44 Varian Medical Systems, Inc. II May-05-2020
45 Viewray, Inc. II Nov-20-2020
46 Viewray, Inc. II Apr-27-2020
47 Viewray, Inc. II Dec-12-2019
48 Viewray, Inc. II May-02-2019
49 Zap Surgical Systems II Sep-14-2022
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