Pentax Ultrasound Video Bronchoscope Recalled for Incorrect Instructions
Pentax of America Inc. is recalling 113 Ultrasound Video Bronchoscopes because they shipped with outdated instructions for use.
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 identifies the issue as a documentation error (incorrect IFUs) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Pentax of America Inc. is recalling 113 units of the EB-1970UK Ultrasound Video Bronchoscope. The recall was initiated because the devices shipped between April 2014 and September 2015 contained Operation and Reprocessing Instructions for Use (IFUs) that were in use prior to the 2014 clearance. Consequently, the devices did not include the cleared Operation and Reprocessing IFUs.
The affected devices were distributed nationwide. The EB-1970UK is intended to provide optical and ultrasonic visualization of, and therapeutic access to, the pulmonary track in adult and pediatric patients.
Healthcare providers should stop using the affected devices and contact Pentax of America Inc. for further instructions regarding the replacement of the instructions for use.
The recalled product
- Product
- Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 113
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)
- EB-1970UK
Distribution
Distributed nationwide across the United States.
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