| Date Initiated by Firm | September 22, 2020 |
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| Date Posted | October 23, 2020 |
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| Recall Status1 |
Terminated 3 on May 16, 2022 |
| Recall Number | Z-0292-2021 |
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| Recall Event ID |
86440 |
| Product Classification |
Medical device data system - Product Code OUG
|
| Product | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), |
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| Code Information |
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 |
| FEI Number |
1000080301
|
Recalling Firm/
Manufacturer |
Pentax of America Inc
3 Paragon Dr
Montvale
NJ
07645-1782
|
| For Additional Information Contact |
973-628-2199 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Software design |
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| Action | URGENT MEDICAL DEVICE CORRECTION notification letters were sent on 9/22/20.
Customer Instructions: Enclosed with this letter is a Field Correction Response Form which identifies the serial numbers of the affected products your facility owns.
PENTAX Medical will be taking a two step approach to contain and correct the problem.
o First, we will contact you to schedule a time for our Field Service to temporarily disable file transfer to endoPortal.
o During the time that file transfers to endoPortal are disabled, you can continue to create and save exam video files. When this issue is resolved, all files recorded during that period will be uploaded and will be available for endoPortal.
o Second, PENTAX Medical is developing a software solution that will be deployed remotely. We will coordinate all updates with your IT administrator.
Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at vigilance@pentaxmedical.com.
Contact Information: PENTAX regrets any inconvenience that this action may cause and appreciates your understanding and cooperation. PENTAX will issue additional communications as further information becomes available. Please be assured that maintaining patient safety and quality is our utmost priority.
If you have any questions regarding this action, please feel free to contact us at: Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com.
An Urgent Medical Device Correction notification letter dated 10/22/20 was sent to customers.
This letter is a clarification of and replaces the letter dated September 2, 2020, which you received previously.
This letter is to inform you that PENTAX Medical ( PENTAX ) is conducting a voluntary corrective action of impacted 9372HD Digital Capture version 1.1.0 or higher and 9310HD Digital Video Capture Module with software version 3.4.0 or |
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| Quantity in Commerce | 39 total |
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| Distribution | US Nationwide and Canada |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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