GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient bo
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 478 Varicam/VG and VG Hawkeye nuclear medicine imaging devices due to a potential safety hazard where fasteners securing the camera to the gantry may become loose, causing a portion of the system to fall onto a patient during a scan. The affected models are H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, and H2508PD. These devices have been distributed worldwide, including throughout the United States, its territories, and numerous countries across multiple continents.
In response to this issue, GE Healthcare is updating the preventative maintenance procedure and schedule for the Nuclear Medicine systems to include an additional check for loose fasteners on the camera-to-gantry connection. The recall record does not specify what actions affected consumers should take.
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: 478 Lot/code info: 0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 10269 208529VG 1078 209334LNVG1 10340 209526milvg 10541 212562VG 1081 225763MVG 000003100-1829 228818MILLVG 00008125-18-18 248338MLO02 10237 248828VG 10326 248937VG 1538 256235OPNM1 10171 262785vg 1039 2894872VG2 1080 2894872VG3 10316 301896VG 10177 304256VG 00000000010-15 304487VG 10156 305612VG 10197 309662SJVG 10539 310231VGH1 10395 312864VG 1058 313299VG 00000000010-63 334794MILVG 1372 361575VG 000000099-4-04 402449SJVG 10189 404605PVGH 1107 407277fvg2 1132 407896FVG1 10211 407933KVG 10438 408947VG 10199 409291HVG 10460 410955VG1 10359 410955VH 10406 412359VG 00000000010-31 413781VG1 00000000010-82 413781VG2 10547 414219VG 10375 414328VG 10534 414384vg 10182 414447VG 3874990 414544VG 5007 414777MIL 10139 414777VG2 10555 414961vg 1141 443643VG 10347 480981NM1 10354 508997VG 10338 510486VG1 1056 512753VG 10481 515263LVG 1035 516256VG 10210 520757NM1 10572 530529VG 10281 540596N3 10190 540953VG 10179 559688NM1 10150 570791HAWK 10193 580355VGACQ 00008125-16-70 58510 00008125-16-89 58582 00008125-18-09 58711 00008125-18-16 58919 00000000017-64 58958 1016 601426VG 10300 602870NM1 10501 605333HAWKEYE 10284 608263VG 10446 608364VG 1119 609267VG 10146 610954VG 1100 615322NM2 10178 615791VG 10041 630801VG 10280 706845VG 10267 707554VG 00000011278NU9 708783VG 3003 714774VG 1126 716694VG 10235 716859VG 1013 718759VG 10263 781278VG 10526 781744VG2 10488 781744VH 10507 804281VG1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.