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U.S. Department of Health and Human Services

Class 2 Device Recall GE Discovery ST PET/CT

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 Class 2 Device Recall GE Discovery ST PET/CTsee related information
Date Initiated by FirmJanuary 26, 2006
Date PostedJune 02, 2006
Recall Status1 Terminated 3 on December 27, 2006
Recall NumberZ-0588-06
Recall Event ID 34935
510(K)NumberK042257 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.
Code Information 617243PETCT, 203688DST, ALLIANCEPETCT30, 203863DST, 973989DST, 908979DST, 212535DST, 412942DST, 814366CTPET, 202715PTCT, 443663DST, 850863FWPET, 863680DST, 251343DST, 832237EHDST, 0002584305, 574535PET, 763257DST, DMSIPCO7, EPHCPASRW1, 801408DST, 949417DST, 406255PET, 805546CT1, 415222CL1, 503692PETCT, 360SALPET, 425228DST, 402390DST1, 201996DST, AH4001PE01, 2558941, 082445040002, 082445160009, 082445160006, 082445160010, 514340DST, 423468PE01, 10495DST01, A4194408, 10094PTM70, 00060DST01, 00060DST02, A5138110, C5123618, A5215931, A99263302, A5111228, A5808512, A5279305, A5645908, YE0010, YE0009, 81DST2547033, ZWL0470, PER10934, 732292DST, ALLIANCEPCT41, DMSIPC15, 763463PC14, ALLIANCEPETCT28, ALLIANCEPETCT29, 972867DST, 082445040003, 2585577DISCPET, A5645911, YE0100, YE0113, YE0404, YE0403, 0834450002, 787269PETCT, 0002592878
FEI Number 2126677
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
FDA Determined
Cause 2		Other
ActionAll affected customers are being sent an 'Important Radiation Safety Notification' letter dated November 10, 2005, that identifies affected units, the associated potential hazards, and the planned modification. A Copy of the Technical Reference Manual will be included with the customer letter.
Quantity in Commerce74
DistributionNationwide, Worldwide. AL, CA, CT, FL, IN, MA, MD, MN, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, Puerto Rico. OUS to include: Austria, Brazil, Canada, China, Columbia, Egypt, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, United Kingdom, Venezuela
Total Product Life CycleTPLC 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 = KPS
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