9372HD Digital Capture recall: Software Issue
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Why was 9372HD Digital Capture recalled?
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All systems with version 1.1.0 or higher; Computer Serial Numbers: 84086-01 84533-01 84090-16 84090-15 84090-14 84090-11 84090-09 84090-10 84090-08 84088-13 84088-11 84528-08 84087-06 84087-03 84538-06 84088-14 84089-02 84089-06 84089-03 84529-04 84528-05 81536-06 84091-01 84089-16 81536-12 84532-11 81538-05 84090-02 84089-13 84089-12 84090-06 84087-04 84531-12 84531-11 84531-10 84531-13 84091-16 84533-11 84533-12
- Product
- 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
- Recalling firm
- Pentax of America Inc
- Quantity
- 39 total
- Distribution
- US Nationwide and Canada
- Recall date
- November 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)