Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent
Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unexpected mechanical movement) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed fatalities or hospitalizations.
Plain-English summary
Carestream Health, Inc. is recalling 470 units of the CS 8100 3D dental X-ray device (Catalog # 5311162, 5311188). The recall affects all serial numbers of the affected devices. The units were distributed worldwide, including 127 units in the United States and 343 units internationally in India and Switzerland.
The recall was initiated because the device head may descend unexpectedly. This malfunction presents a risk of physical injury to patients or healthcare professionals using the equipment. The device is intended to produce tomographic digital panoramic and three-dimensional digital X-ray images of the dentomaxillo-facial area for diagnostic support.
Healthcare professionals and consumers who possess these devices should stop using them immediately. They should contact Carestream Health, Inc. for instructions on how to return the device or obtain a repair or replacement.
The recalled product
- Product
- CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic…
- Manufacturer
- Carestream Health, Inc.
- Category
- Medical Device — Dental Imaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers of affected devices.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Carestream Health, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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