The Recall Desk

FDA (Devices) recall action 73985

Pentax Medical Company recalled 6 products on 2016-08-03

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-08-03
Critical
0
Units
23,755

Why these products were recalled

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.

    Product
    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum.…
    Category
    Distribution
    0 states