MAUDE Adverse Event Report: DENTSPLY LLC XIOS AE USB PACKAGE; UNIT, X-RAY, INTRAORAL

Catalog Number	6724723
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While the customer was using a part of an intraoral sensor system, xios ae usb package, they allege experiencing connectivity issues when an x-ray image was taken or an additional image was required.No injury was reported from the alleged event.
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.Usb 3 firmware v1.4 contains an issue in the portion of code used to optimize sensor performance.If the optimization occurs during an exposure or sensor readout, there is a chance that the resulting image will be corrupted.Image data following the point of corruption will consist of data that was previously held in the memory of the usb device.As a result, the presented image may contain a portion of data from a previous exposure.In general, this would be obvious to the user since the presented image would either contain obvious artifacts or different anatomy than expected.Field service evaluation- nitial log (b)(6) 2026 9:48:30 am (b)(6).Warranty: yes dealer on-site: no billable: no billing accepted: na billing approved by: na 90 day expiration date: 05/06/2026.Remote access: yes sidexis version: na server location: na pdata remote location: na rcu location (if applicable): na practice management: curve workstation(s): op07-pc scout check: yes.Firmware: 1.5.140 plug-in version: 3.2 exposure count: na unit ip address: na.Troubleshooting description: remoted into op07-pc, checked software installed, they are using curve capture 2.32.3 and ioss 3.2 checked usb power management, they are off.Checked intraoral sensor app, usb interface is detected.Checked event viewer logs, there is a warning about realtek ethernet disconnected from the network.Checked power saving for etheret, disabled power saving.Noticed a few clipesu.Exe errors (not sure if related) ran sfc and dism, fixed os corruption.Ae clip installed, usb interfaces stay in the room.Office is using a nomad.Usb cable connects to the back of the computer.Remoted into op4 (windows 10) and op1 (windows 11), uninstalled ioss 3.2 then installed legacy 1.1 driver with cdr twain, restarted curve capture then we were able to take a bitewing series without issues.Solution description (b)(6) 2026 , 11:31:54 , (b)(6).Solution description: attached logs for op7, op4 and op1.Caller stated they had the most issues in op4 and op1.Uninstalled ioss 3.2, then installed legacy drivers to determine if this is software or hardware related.I asked if they had to retake images, they said yes for the ones where the image did not take.Caller reported no injuries.

• Brand Name: XIOS AE USB PACKAGE
• Common Device Name: UNIT, X-RAY, INTRAORAL
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24429969
• Report Number: 2424472-2026-00571
• Device Sequence Number: 18740184
• Product Code: EAP
• UDI-Device Identifier: D00367247231
• UDI-Public: D00367247231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6724723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown