FMI 78099
< 의료기기 회수 계획 공표>
의료기기법 제31조에 따라 아래의 의료기기에 대하여 회수함을 공표합니다.
가.회수의무자(연락처): 지이헬스케어코리아㈜ (1544-6119)
나.회수대상의료기기: 이동형초음파영상진단장치
다.
| 모델명 | 인증번호 | 품목명 |
|---|---|---|
| Venue Go | 수인 19-4414 호 | 이동형초음파영상진단장치 |
가.위해성 정도: 의료기기법 시행규칙 제 52조 제2항 제3호
나.제조일자 또는 사용기한: 해당 없음
다.제조번호: 하단 별첨 1 참고
라.회수사유:
마.회수 시작 일자: 2023. 09.18.
바.공표자료 작성 연월일: 2023. 09. 21.
별첨 1. 모델명 및 제조번호
| 모델명 | 제조번호. |
| Venue Go | 00000VGB000149 |
| Venue Go | 00000VGB000302 |
| Venue Go | 00000VGB000242 |
| Venue Go | 00000VGB000246 |
| Venue Go | 00000VGB000436 |
| Venue Go | 00000VGB000970 |
| Venue Go | 00000VGB000968 |
| Venue Go | 00000VGB000971 |
| Venue Go | 00000VGB000726 |
| Venue Go | 00000VGB000929 |
| Venue Go | 00000VGB001509 |
| Venue Go | 00000VGB001501 |
| Venue Go | 00000VGB001550 |
| Venue Go | 00000VGB001520 |
| Venue Go | 00000VGB001503 |
| Venue Go | 00000VGB001913 |
| Venue Go | 00000VGB001968 |
| Venue Go | 00000VGB001985 |
| Venue Go | 00000VGB001535 |
| Venue Go | 00000VGB001975 |
| Venue Go | 00000VGB002327 |
| Venue Go | 00000VGB000969 |
| Venue Go | 00000VGB002321 |
| Venue Go | 00000VGB002148 |
| Venue Go | 00000VGB002426 |
| Venue Go | 00000VGB002458 |
| Venue Go | 00000VGB002467 |
| Venue Go | 00000VGB002464 |
| Venue Go | 00000VGB002635 |
| Venue Go | 00000VGB002638 |
| Venue Go | 00000VGB002701 |
| Venue Go | 00000VGB002728 |
| Venue Go | 00000VGB002584 |
| Venue Go | 00000VGB002619 |
| Venue Go | 00000VGB002423 |
| Venue Go | 00000VGB002905 |
| Venue Go | 00000VGC000296 |
| Venue Go | 00000VGB002910 |
| Venue Go | 00000VGB002912 |
| Venue Go | 00000VGB002911 |
| Venue Go | 00000VGB002909 |
| Venue Go | 00000VGC000284 |
| Venue Go | 00000VGB002984 |
| Venue Go | 00000VGC000443 |
| Venue Go | 00000VGC000563 |
| Venue Go | 00000VGC000683 |
| Venue Go | 00000VGC000555 |
| Venue Go | 00000VGB002611 |
| Venue Go | 00000VGC000664 |
| Venue Go | 00000VGC000740 |
| Venue Go | 00000VGC004045 |
| Venue Go | 00000VGC004047 |
| Venue Go | 00000VGC004044 |
| Venue Go | 00000VGC004089 |
| Venue Go | 00000VGC004092 |
| Venue Go | 00000VGC004046 |
| Venue Go | 00000VGC004122 |
| Venue Go | 00000VGC004211 |
| Venue Go | 00000VGC004192 |
| Venue Go | 00000VGC004313 |
| Venue Go | 00000VGC004333 |
| Venue Go | 00000VGC004392 |
| Venue Go | 00000VGC004349 |
| Venue Go | 00000VGC000857 |
| Venue Go | 00000VGC006188 |
| Venue Go | VGC006206 |
| Venue Go | 00000VGC006215 |
| Venue Go | 00000VGC006336 |
| Venue Go | 00000VGC006295 |
| Venue Go | 00000VGC006300 |
| Venue Go | 00000VGC006325 |
| Venue Go | 00000VGC006414 |
| Venue Go | 00000VGC006415 |
| Venue Go | 00000VGC006530 |
| Venue Go | 00000VGC006768 |
| Venue Go | 00000VGC006800 |
| Venue Go | 00000VGC006762 |
| Venue Go | 00000VGC006767 |
| Venue Go | 00000VGC006981 |
| Venue Go | 00000VGC007335 |
| Venue Go | 00000VGC007331 |
| Venue Go | 00000VGC007334 |
| Venue Go | 00000VGC007327 |
| Venue Go | 00000VGC007366 |
| Venue Go | 00000VGC007332 |
| Venue Go | 00000VGC007329 |
| Venue Go | 00000VGC007328 |
| Venue Go | 00000VGC007458 |
| Venue Go | To Be Confirmed |