Definium 5000 Manual Lawn

03.08.2019
93 Comments

The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator. Poplar streets and $5,000, if that amount was matched by the city. The gifts, a. The lawn was planted artistically in shrubbery to add a setting for the building. Interstate Public Service. Seymour Water Co. Seymour Telephone Co. Balance on Hand. Total Expenditures.

-
Ge definium service manual
510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC


New SearchBack to Search Results
Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System.
Date Initiated by FirmDecember 17, 2007
Date PostedSeptember 04, 2008
Recall Status1Terminated 3 on September 10, 2008
Z-1133-2008
Recall Event ID48144
K063283
Digital Radiographic Imaging System - Product CodeKPR
ProductGE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493.
The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/power unit.
Code InformationModel Number 5220493: PC0127XR06, M1973721
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
Radiation Control for Health and Safety Act
A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.
14 devices (12US & 2 OUS)
MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR and Original Applicant = SEDECAL S.A.
-
Lawn
510(k)DeNovoRegistration & ListingAdverse EventsRecallsPMAHDEClassificationStandards
CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC


Ge definium

Definium 5000 Manual Lawn Mower

New SearchBack to Search Results
Class 2 Device Recall Definium 5000 Xray System
Date Initiated by FirmMarch 24, 2009
Date PostedSeptember 25, 2009
Recall Status1Terminated 3 on May 16, 2012
Z-1118-2009
Recall Event ID51490
K063283
Stationary X-Ray System - Product CodeKPR
ProductDefinium 5000 X-ray System, model number 5220493 and 5220393-2
Code InformationSerial Numbers: 00000GEHC00049, 00000GEHC00011, 00000GEHC00009 00000GEHC00035 00000GEHC00041 00000GEHC00028 00000GEHC00026 00000GEHC00078 00000GEHC00051 00000GEHC00043 00000GEHC00008 00000GEHC00016 00000GEHC00013 00000GEHC00058 00000GEHC00110 00000GEHC00120 00000GEHC00042 00000GEHC00047 00000GEHC00069 00000GEHC00057 00000GEHC00019 00000GEHC00066 00000GEHC00085 00000GEHC00046 00000GEHC00076 00000GEHC00015 00000GEHC00018 00000GEHC00124 00000GEHC00095 00000GEHC00022 00000GEHC00100 00000GEHC00125 00000GEHC00117 00000GEHC00027 00000GEHC00112 00000GEHC00054 00000GEHC00062 00000GEHC00119 00000GEHC00118 00000GEHC00048 00000GEHC00089 00000GEHC00114 00000GEHC00121 00000GEHC00107 00000GEHC00108 00000GEHC00036 00000GEHC00030 00000GEHC00045 00000GEHC00017 00000GEHC00064 00000GEHC00075 00000GEHC00077 00000GEHC00115 00000GEHC00053 00000GEHC00106 00000GEHC00007 00000GEHC00021 00000GEHC00023 00000GEHC00065 00000GEHC00020 00000GEHC00083 00000GEHC00105 00000GEHC00111 00000GEHC00031 00000GEHC00025 00000GEHC00104 00000GEHC00067 00000GEHC00133 00000GEHC00101 00000GEHC00072 00000GEHC00024 00000GEHC00087 00000GEHC00059 00000GEHC00012 00000GEHC00068 00000GEHC00034 00000GEHC00123 00000GEHC00073 00000GEHC00050 00000GEHC00113 00000GEHC00052 00000GEHC00006 00000GEHC00005 00000GEHC00131, and 00000GEHC00131.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.
Radiation Control for Health and Safety Act
A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.
85
Nationwide Distribution
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR and Original Applicant = SEDECAL S.A.