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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a missing component (isolation transformer) which is a safety compliance issue rather than a direct biological or acute physical hazard with reported harm.
Plain-English summary
Pentax of America Inc is recalling 241 units of 9310HD Digital Video Capture Modules. These devices are used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
The recall was initiated because Pentax Medical did not always provide 9175 isolation transformers with the 9310HD computer systems. These transformers are required for use with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
The affected units were distributed worldwide and nationwide in the US. Users should check their inventory for the specific serial numbers listed in the recall notice and contact Pentax of America for instructions on obtaining the necessary transformers or replacing the units.
The recalled product
- 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.
- Manufacturer
- Pentax of America Inc
- Affected units
- 241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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