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Manufacturers
AGFA HealthCare Australia
제조사 모회사 (2017)
Agfa-Gevaert NV
Source
DHTGA
9 Events
Drystar DT 2 C Hardcopy Film 14" x 17" 의 리콜
NX workstation with NX 3.0.8950 image processing software 의 리콜
DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affected 의 리콜
Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411 의 리콜
DX-D 600 X-ray System, Versions below 3.6 의 리콜
DX-D 100 Digital Radiography X-Ray SystemAll Units 의 리콜
IMPAX RIS 5.8 and higher (Picture archiving and communication system software) 의 리콜
DX-D 100 (Mobile diagnostic x-ray generator) 의 리콜
IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건
Drystar DT 2 C Hardcopy Film 14" x 17"
모델명 / 제조번호(시리얼번호)
Drystar DT 2 C Hardcopy Film 14" x 17"Reference: EKMCUBatch Numbers: 36650011 (exp 2018-06) and 69030031 (exp 2018-10)ARTG Number: 119352 (AGFA HealthCare Australia - Photographic film, diagnostic imaging)
NX workstation with NX 3.0.8950 image processing software
모델명 / 제조번호(시리얼번호)
NX workstation with NX 3.0.8950 image processing softwareARTG Numbers: 119463, 173861, 178856
DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Di...
모델명 / 제조번호(시리얼번호)
DX-D 600 Digital Radiography System (general purpose x-ray system)Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affectedARTG Number:173861
Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411
모델명 / 제조번호(시리얼번호)
Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411ARTG Number 178856
DX-D 600 X-ray System, Versions below 3.6
모델명 / 제조번호(시리얼번호)
DX-D 600 X-ray System, Versions below 3.6All full automatic & semi-automatic devices below version 3.6ARTG Number: 173861
의료기기 분류등급
Radiology Devices
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