Z-2744-2017Class II

9400 Laryngeal Strobe

Name: Z-2744-2017 9400 Laryngeal Strobe
Creator: Pentax of America Inc
Published: 2017-04-13
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2017-04-13 / Terminated / root cause: design

FDA source

Pentax of America Inc began a recall of 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal... on 2017-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2744-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2017-07-18
Terminated: 2019-03-22
Recalling firm: PENTAX of America, Inc.
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.
Product code: GCW Transformer, Endoscope
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.
Root cause tag: design
FDA root cause: Device Design
Action: Pentax notified their customers on 4/13/2017 via USPS.
Quantity in commerce: 241 units in total
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2744-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2742-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-18
Z-2743-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-18
Z-2744-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-18
Z-2745-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-18

Product code GCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)