Pentax Video Colonoscope Recall for Missing Operation and Reprocessing Instructions
Pentax of America is recalling video colonoscopes shipped between April 2014 and September 2015 because they included outdated instruction manuals and lacked required reprocessing adaptors.
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Our severity reasoning: This is an FDA Class II recall involving missing or outdated documentation and components, which fits the rubric criteria for moderate severity as it involves labeling/documentation issues without reported injuries.
Plain-English summary
Pentax of America Inc is initiating a product correction for several model numbers of Pentax Video Colonoscopes. The affected devices were shipped between the clearance date of April 2014 and September 2015. The recall involves 5,090 units in the United States and 14,209 units outside the United States, distributed nationwide in the US and in Japan.
The recall is being conducted because the affected colonoscopes contained operation and reprocessing Instructions for Use (IFUs) that were in use prior to the 2014 clearances. Consequently, these devices did not include the cleared operation IFU, the updated reprocessing IFU, or the dedicated reprocessing adaptor for applicable models. The affected model numbers are EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK, and EC-3890TLK.
Healthcare facilities and users should verify their equipment against the listed model numbers and contact Pentax of America Inc for further instructions regarding the product correction.
The recalled product
- Product
- Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
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 (6)
- Model #'s EC-2990LI
- EC-3490LI
- EC-3490LK
- EC-3490TLI
- EC-3890LI
- EC-3890LK and EC-3890TLK
Distribution
Distributed nationwide across the United States.
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