Reported Feb 26, 2014 · Terminated
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
- Lot codes and dates
- FMI 13715 Serial # System ID8.30458E+13 00000012722PT5 8.3045E+13 00000012738PT1 8.3045E+13 00000012871PT0 4065738 00000012881PT9 4108707 00000012909PT8 83045062157413 00000012921PT3 8.30452E+13 00000013020PT3 8.30452E+13
93 of 93 codes
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
, A5330718 ,00000013127PT6411915400000012600PT3A512454100000012638PT3A536781000000012644PT1A536630500000012655PT7B580173600000012756PT3A5114213500000012877PT7A5105113100000012887PT6A5127316700000012930PT4A5330720
FMI 13716 Serial # System ID63 of 63 codes
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
Shipped 00000010964PT5 Shipped 00000011377PT9 Shipped 00000011427PT2 Shipped 00000013032PT8 Shipped137 of 137 codes
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
0828450016_00000011431PT4604877D60000000011527PT9613761HIPET200000011399PT3514848PET00000011298PT7604877D69000000011981PT88244503001100000012307PT58244516001400000012431PT38244501000800000012705PT08244507000400000012708PT48244516001800000012741PT58244504001600000012785PT28244510001800000012984PT18244514000700000012136PT8
Shipped00000012796PT908244510001700000012804PT108244512000800000012912PT28244521000900000012918PT908244505000900000013051PT808244512000900000011831PT5PET11831PT500000011503PT0HR4199PE0100000012065PT9CS1338PT0100000011120PT3CS1318PT0100000010017PT2DK1054PT1500000010275PT6DK1047PT0100000011117PT9FI1015MN0200000011216PT9FI1003MN0800000012361PT2
Shipped77 of 77 codes
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
PET12015PT4_141 of 141 codes
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
Shipped 00000012335PT6 Shipped73 of 73 codes
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
00000011436PT300860DST0200000012054PT3IE1510MN1900000010083PT470001DST0200000010220PT270065DST0100000010715PT100139DST01
- FMI 13715 Serial # System ID
- Amount recalled
- 376 (101 US, 275 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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