Pentax of America Inc: Medical Device Recall in 2017 - (Recall #: Z-2743-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 13, 2017

Date Posted: July 26, 2017

Recall Number: Z-2743-2017

Event ID: 77137

Reason for Recall:

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.

Status: Terminated

Product Quantity: 241 units in total

Code Information:

80847 38953-09 40156-01 40156-09 40158-15 40669-02 40669-09 40670-05 42094-05 45852-06 46800-05 47452-01 48653-02 48653-03 49242-02 72872-49A 80361-14 80362-01 80362-02 80365-05 80399-05 80399-09 80481-07 80841-02 80842-05 80847-06 80878-07 80879-06 80879-08 80880-01 80881-05 80883-03 80884-03 80886-06 80886-11 80886-13 80887-02 80887-08

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated