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CS 3600Recalls & reported problems

Carestream Dental LLC · CS 3600 I/O 3D SCANNER · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60192156568748), received between Feb 23, 2021 and Apr 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Defective Component2
  • Material Separation2

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2021Material Separation; Defective Component; Material Separation; Defective Component

    THIS IS A CORRECTED REPORT. ORIGINAL MDR NUMBER USED CFN FOR CARESTREAM HEALTH. THE ORIGINAL MDR NUMBER WAS: 131703-2021-00001. THE CORRECTED MDR NUMBER USES THE CORRECT FEI FOR CARESTREAM DENTAL LLC: 3002522649-2021-00001. WHEN USING THE CS 3600 ACCESSORY: CS 3600 SINGLE USE NORMAL TIP, THE MIRROR CAN BE DETACHED FROM THE UNIT. WHEN THIS EVENT OCCURRED, THE MIRROR FELL FROM THE UNIT INTO THE PATIENT'S MOUTH. THE PATIENT WAS ABLE TO REMOVE THE MIRROR AND THE PATIENT DID NOT SUSTAIN ANY INJURIES. THE SIZE OF THE MIRROR (22MMX13MMX1.5MM) MAKES IT POSSIBLE FOR THE MIRROR TO BE SWALLOWED OR ASPIRATED. IF THE MIRROR IS SWALLOWED OR ASPIRATED, SURGICAL INTERVENTION WOULD BE REQUIRED TO REMOVE THE MIRROR.

    Patient problems: Foreign Body In Patient

    MAUDE report 11648699 ↗
  • MalfunctionFeb 23, 2021Material Separation; Defective Component; Material Separation; Defective Component

    WHEN USING THE CS 3600 ACCESSORY: CS 3600 SINGLE USE NORMAL TIP, THE MIRROR CAN BE DETACHED FROM THE UNIT. WHEN THIS EVENT OCCURRED, THE MIRROR FELL FROM THE UNIT INTO THE PATIENT'S MOUTH. THE PATIENT WAS ABLE TO REMOVE THE MIRROR AND THE PATIENT DID NOT SUSTAIN ANY INJURIES. THE SIZE OF THE MIRROR (22MMX13MMX1.5MM) MAKES IT POSSIBLE FOR THE MIRROR TO BE SWALLOWED OR ASPIRATED. IF THE MIRROR IS SWALLOWED OR ASPIRATED, SURGICAL INTERVENTION WOULD BE REQUIRED TO REMOVE THE MIRROR.

    Patient problems: Foreign Body In Patient

    MAUDE report 11366583 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.