Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use
Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is a Field Correction to revise documentation (Instructions for Use), which aligns with the rubric criteria for documentation issues and packaging-only problems.
Plain-English summary
Pentax of America Inc is initiating a Field Correction for Rigid Laryngostroboscopes, Models 9106 and 9108. The purpose of this action is to revise the Instructions for Use for these medical devices.
The affected instruments are intended to observe glottic action using a stroboscopic light source and are inserted per-orally. A total of 2,056 units are involved in this field correction, with 1,545 units distributed in the United States and 511 units distributed outside the United States.
The distribution pattern includes the United States (nationwide) and numerous countries worldwide, including Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom. Healthcare facilities and users should contact Pentax of America Inc for details regarding the revised Instructions for Use.
The recalled product
- Product
- Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
- Manufacturer
- Pentax of America Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model #'s 9106 and 9108
Distribution
Distributed nationwide across the United States.
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