FDA Medical Device Recalls (openFDA)
Pentax of America Inc: 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.
- Recall number
- Z-2745-2017
- Recalling firm
- Pentax of America Inc
- 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.
- Status
- Terminated
- Initiated
- 2017-04-13
- Posted
- not on file
- Terminated
- 2019-03-22
- Reason
- 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.
- Root cause
- Device Design
- Action
- Pentax notified their customers on 4/13/2017 via USPS.
- Quantity
- 241 units in total
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- 40552 22679-05 23546-06 23546-07 24036-06 24045-03 24045-06 24045-08 24045-09 24049-01 24049-03 24049-08 24231-10 24556-01 24556-06 24965-07 25282-03 25351-06 25459-01 25459-07 25459-08 25459-09 25461-01 25461-03 25461-05 25461-07 25461-09 25466-07 25466-08 25964-01 25964-03 25964-11 25965-02 25965-05 25965-12 26035-13 26055-02 26055-13 26055-18 26056-04 26056-05 26056-08 26057-03 26057-18 26058-18 26058-20 26870-09 26871-02 26871-02 26871-03 26871-03 26871-07 26871-11 26871-12 26871-14 26871-17 26871-18 26872-05 26872-06 26872-08 26872-10 26872-16 26872-18 26872-18 26872-20 26873-10 26873-16 26873-20 28073-02 28668-11 28670-03 28670-07 28670-12 28670-14 28672-14 28672-18 28674-03 28674-17 28676-08 29880-09 30001-02 30598-04 30598-09 30598-21 30599-04 30599-06 30599-13 30600-02 30600-03 30600-06 30601-11 30601-14 31523-07 31523-15 31523-21 31524-01 33226 33226-05 33226-06 33226-16 33413-05 33413-10 34162-07 34162-09 34162-20 34593-07 35263-06 35263-10 36135-14 36315-02 36315-13 36315-19 36600-13 36890-11 36890-12 36890-19 37419-13 37835-15 38524-09 38776-05 38850-01 38850-04 38850-06 39951-05 39952-024 39952-03 39952-04 41241-10 41577-09 41577-19 41577-20 41577-21 41861-14 41861-15 41861-16 42024-08 441046-01 45770-03 94965-03 48029-01 48029-06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCW
- Firm FEI
- 1000080301
- Firm city
- Montvale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28