Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers
Pentax Medical is recalling 241 laryngeal strobe systems 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. The source text does not report any illnesses, injuries, or deaths, and the hazard involves a missing component rather than a direct biological or structural failure causing immediate harm.
Plain-English summary
Pentax of America Inc is recalling 241 units of 9200C and 9200D Laryngeal Strobe systems. The recall is due to the fact that Pentax Medical did not always provide the required 9175 isolation transformers with these devices. These transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
The affected products were distributed worldwide and nationwide in the United States. The recall involves specific serial numbers listed in the agency's structured data. The 9310HD component 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.
Consumers and healthcare providers should stop using the affected units and contact Pentax of America Inc for further instructions on the recall.
The recalled product
- 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.
- Manufacturer
- Pentax of America Inc
- Hazard
- 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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