Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent
Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect (unexpected device head descent) that poses a significant risk of injury to patients or operators, meeting the criteria for a Severe rating.
Plain-English summary
Carestream Health, Inc. is recalling the CS 8100 panoramic X-ray device, which is intended to produce tomographic digital panoramic X-ray images of the dento-maxillo-facial region for diagnostic support. The recall involves catalog numbers 5303045, 5311129, 5303060, and 5303110. The device is being recalled because the device head may descend unexpectedly.
Approximately 3,110 units were distributed, with 863 units in the United States and 2,247 units internationally. The affected devices were distributed in various US states and in India and Switzerland. All serial numbers of the affected devices are included in the recall.
Healthcare professionals should contact Carestream Health for further instructions regarding the recall and potential corrective actions for the affected units.
The recalled product
- Product
- CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic…
- Manufacturer
- Carestream Health, Inc.
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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