Agency classClass IIOur severity:High FDA (Devices)·Z-2744-2017·Announced 2017-07-26

Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers

Pentax Medical is recalling 241 laryngeal strobe systems because isolation transformers were not always provided, posing a potential electrical safety risk.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a missing safety component (isolation transformer) in a medical device, which presents a risk of harm (electrical shock) even though no specific injuries are reported in the source text.

Plain-English summary

Pentax Medical is recalling 241 units of the 9400 Laryngeal Strobe and related computer systems. The recall is being conducted because the manufacturer 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 are used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, as well as audio data, for medical and pedagogical applications. The recall covers units distributed worldwide and across the United States.

Healthcare providers and users of these devices should contact Pentax Medical to verify if their specific unit is affected and to obtain the necessary isolation transformer. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer: Pentax of America Inc
Category: Medical Device — Diagnostic Imaging
Hazard: electrical-shock
missing-component
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.

See all 4 products in this recall →

Same manufacturer · Pentax of America Inc

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Same hazard · electrical shock