Pentax 9372HD Digital Capture Software Recall for Patient Data Error
Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.
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 'High' severity criteria for potential patient data errors.
Plain-English summary
Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal) system. The recall covers systems with version 1.1.0 or higher, 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. This error does not occur during the initial exam or review but may become evident during a follow-up review.
Healthcare providers should contact Pentax of America Inc. for instructions on how to resolve the software issue. The specific computer serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- 9372HD Digital Capture (ver. 1.1.0 + w/ 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 1.1.0 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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