Z-0588-06

Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN...

Name: Z-0588-06 Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN...
Creator: General Electric Med Systems LLC
Published: 2006-01-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-01-26 / Terminated

FDA source

General Electric Med Systems LLC began a recall of 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... on 2006-01-26. The reason FDA records is "The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0588-06
Status: Terminated
Initiated: 2006-01-26
Posted: 2006-06-02
Terminated: 2006-12-27
Recalling firm: GE Healthcare
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
FDA root cause: Other
Action: All 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 commerce: 74
Distribution: Nationwide, 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
Product codes and lots: 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

Product code KPS

K042257Class IIDiscovery St Pet/ct Imaging System with an Alternate Detector OptionGeneral Electric Co. / cleared 2004-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)