The Recall Desk

FDA (Devices) recall action 77137

Pentax of America Inc recalled 4 products on 2017-07-26

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-07-26
Critical
0
Units
964

Why these products were recalled

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.

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.

1–4 of 4

  • HighFDA (Devices)··2017-07-26

    Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers

    Pentax Medical is recalling 241 laryngeal strobe systems because isolation transformers were not always provided, posing a potential electrical safety risk.

    Product
    9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-07-26

    Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers

    Pentax Medical is recalling 241 laryngeal strobe systems because they were not always provided with required 9175 isolation transformers.

    Product
    9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-07-26

    Pentax 9310HD Digital Video Capture Modules Recalled for Missing Transformers

    Pentax of America is recalling 241 units of 9310HD Digital Video Capture Modules because they were not always provided with required 9175 isolation transformers.

    Product
    9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-07-26

    Pentax Medical Recalls Video Systems Due to Missing Isolation Transformers

    Pentax Medical is recalling 241 units of 7245C, 7245C/E, and 7245D Computer Digital Video Systems because they may have been shipped without required 9175 isolation transformers.

    Product
    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical application
    Category
    Distribution
    0 states