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PENTAX OF AMERICA, INC. · Model 9175 · UDI-DI 04961333230334

GCW Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Isolation Transformer

Recalls

Date	Firm	Reason
2017-04-13	Pentax of America Inc	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.
2017-04-13	Pentax of America Inc	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.
2017-04-13	Pentax of America Inc	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.
2017-04-13	Pentax of America Inc	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.
2015-02-11	EXP Pharmaceutical Services Corp	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 r
2015-02-11	EXP Pharmaceutical Services Corp	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 r

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.