GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H300
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 2,479 GE Healthcare Infinia nuclear medicine systems distributed worldwide, including throughout the United States and numerous international locations. The recall addresses a safety hazard where loose fasteners that secure the camera to the gantry could allow a portion of the system to fall onto a patient during a scan. GE is responding by updating the preventative maintenance procedure and schedule for these systems, including an additional check for loose fasteners.
The record does not specify a remedy or instructions for affected consumers to follow.
Written by software from the official notice below. Not reviewed by a lawyer.
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Reason for recall: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. Distribution: Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, IS Quantity: 2479 Lot/code info: 15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001 906776INF 16005 615768SCNM1 16015 717782INF 16018 907562NM1 16033 318681INFINIA 16036 920738INF 16043 210921NM1 16045 941637INF 16051 507345INF1 16054 630801INF 16065 860350INIF 16071 763UNTYINFI 16075 937328INF2 16083 973625INFINIA 16084 518828INF 16088 908522INFINIA 16098 203325INF2 16111 956350NM1 16118 814533INF 16123 716366INF 16162 704783INFI3 16166 717627INFINIA 16436 203325INF 16140 110034NU04 16022 905372INFINIA 16039 905731INFINIA 16044 519749INFINIA 16072 450654INF2 16016 M2269829 16092 V2728105 16114 S4160059 16079 783348NU01 16017 HU1039NM02 16126 83026602101643 16135 A5172907 16142 A5197927 16115 850260061 16130 850260060 16170 850260063 18130 2919654INF 16019 MA1154NM02 16106 O005NU14 16049 45001NUC01 16004 00216NUC11 1505 508427INFINIA 10548 608263INF 15010 727461VG 15013 661633NM1 16006 310543INF1 16007 619482INFINIA 16008 509474INFINIA 16009 434924INF2 16010 605333INFINIA 16013 303320IH 16020 775423INF1 16021 928537INF 16026 941629INF 16028 434924INF1 16029 408259IN1 16030 626570INF1 16035 907562NM2 16037 713785SLINF1 16038 LGMCINF2 16046 757668INF1 16050 989723INF1 16052 206223INF 16055 215952INF 16059 916983INFN1 16062 937328INF1 16069 715839INF 16070 225765INF1 16073 989723INF2 16082 516570INF 16109 920684INF 16110 408559IN1 16
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.