CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
9310HD Digital Video Capture Module recalled by Pentax of America
Pentax of America is recalling 9310HD Digital Video Capture Module, distributed nationwide in the US. The recall was initiated on 22 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0293-2021
- FDA event ID
- 86440
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2020
- FDA classified
- 23 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 22 Sep 2020 | Recall initiated by company | |
| 23 Oct 2020 | Classified by FDA | +31 days |
| 4 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Where it was distributed
US Nationwide and Canada
Questions about this recall
Why was it 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.
Which lots are affected?
All systems with version 3.4.0 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
Where was it sold?
US Nationwide and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 86440This product is part of a recall event; the main page for the event is 9372HD Digital Capture (ver recalled by Pentax of America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 9372HD Digital Capture (ver recalled by Pentax of America | Pentax of America | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Water bottle assembly recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
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| Device | CLASS II | Ion Torrent Genexus Dx recalled by Life Technologies Holdings Pte | Life Technologies Holdings Pte | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |