Pentax Ultrasound Video Gastroscope Recall Due to Instruction Error
Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.
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 hazard is a labeling error in the instructions for use regarding the disinfection step, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination issues without reported injuries.
Plain-English summary
Pentax of America Inc is recalling 116 units of the Ultrasound Video Gastroscope, Model EG-3870UTK, in the United States. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
The recall is due to an error in the reprocessing instructions found in Revisions 13 and 14 of IFU Z845, which are used with the EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the instructions incorrectly indicate that the cleaning detergent solution should remain in contact with all internal channels and external endoscope surfaces. The instructions should state that the disinfecting solution, not the cleaning detergent, should be used for this step.
The affected units were distributed nationwide. Users should refer to the specific recall notice for instructions on how to proceed with the recall.
The recalled product
- Product
- Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Affected units
- 116
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 (20)
- H110516
- H110619
- H110635
- H110643
- H110624
- A110407
- A110411
- H110507
- A110352
- A110444
- A110417
- A110419
- H110493
- H110494
- H110522
- H110584
- H110586
- H110590
- H110591
- H110559
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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