Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, l
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 255 of its Discovery NM/CT 670 dual detector nuclear imaging systems sold worldwide, including throughout the United States and numerous international locations. The recall addresses a potential safety hazard where fasteners securing the camera to the gantry may become loose, allowing a portion of the system to fall onto a patient during a scan.
In response to this issue, GE is updating the Preventative Maintenance procedure and schedule for these systems and adding an additional Preventative Maintenance check specifically for loose fasteners on the Nuclear Medicine systems. The recall record does not specify a remedy or instructions for affected consumers.
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: 255 Lot/code info: 21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21188 415353D670 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 SAN00215 615893MMCT1 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 00000000096BH8 0910265076 21001 010120NU19 21008 110022NU05 21034 030133N
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.