FDA Device recall Z-2743-2017
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video…
- FDA Device
- Class II
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class II recall of 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video… by Pentax, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2743-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-13 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax |
| Distribution | US |
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.
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.
Identifiers
| code_info | 80847 38953-09 40156-01 40156-09 40158-15 40669-02 40669-09 40670-05 42094-05 45852-06 46800-05 47452-01 48…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2743-2017%22
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