Transformer, Endoscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- EXP Pharmaceutical Services CorpTerminatedJul 24, 2015
Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Z-2217-2015 · View FDA record ↗ - EXP Pharmaceutical Services CorpTerminatedJul 24, 2015
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm;
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Z-2219-2015 · View FDA record ↗ - Pentax of America IncTerminatedUnknown
7245C, 7245C/E, 7245D
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Z-2742-2017 · View FDA record ↗ - Pentax of America IncTerminatedUnknown
9310HD
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Z-2743-2017 · View FDA record ↗ - Pentax of America IncTerminatedUnknown
9400
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Z-2744-2017 · View FDA record ↗ - Pentax of America IncTerminatedUnknown
9200C and 9200D
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Z-2745-2017 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Mardav Solutions Ltd
Manchester, GB
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Worldwide Supplies Limited
Hong Kong, HK
Mainline Medical Dental Supply
North York Ontario, CA
Heager Gmbh
HAAN North Rhine-Westphalia, DE
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Pentax Of America, Inc.
MONTVALE, NJ, US
Suzhou Shangchuang Technology Service Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
1 clearances for this product code