Pentax 9310HD Digital Video Capture Module Recalled for Software Error
Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with the 9263 endoPortal. The recall covers systems distributed in the United States and Canada.
The recall is due to an intermittent software issue where an exam video for one patient might be copied to another patient's record. This error does not occur during the initial exam or review but may become evident during a follow-up review.
Healthcare facilities should contact Pentax of America Inc for instructions on how to resolve the software issue. The source text does not specify a specific action for consumers, as the product is a medical device used in clinical settings.
The recalled product
- Product
- 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
- Manufacturer
- Pentax of America Inc
- Affected units
- 39
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)
- All systems with version 3.4.0 or higher
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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