Carestream Dental CS 3600 Tips Recalled for Detachment Risk
Carestream Dental is recalling CS 3600 Single Use Normal Tips because the mirror may become detached and fall from the unit.
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 (falling object) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Carestream Dental, LLC is recalling 11,400 units of Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216. These devices are used to record the topographic characteristics of teeth or dental impressions in three dimensions.
The recall was initiated because the mirror on the device may become detached and fall from the unit. This presents a potential hazard to patients or dental professionals during use.
The affected devices were distributed worldwide and nationwide in the United States, specifically in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, and IN, as well as in Canada. All lot numbers are affected. Consumers and dental professionals should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
- Manufacturer
- CARESTREAM DENTAL, LLC
- Category
- Medical Device — Dental Imaging
- Hazard
- Affected units
- 11,400
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 lot numbers
Distribution
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