Recall Z-1378-2015— Carestream Health, Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health, Inc., initiated 2015-01-08, terminated 2017-04-20. It names one FDA 510(k) clearance: K133406. 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 support for pediatric and adult patient.. Reason: Units device head descended unexpectedly.
- Recalling firm
- Carestream Health, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-08
- Terminated
- 2017-04-20
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 support for pediatric and adult patient.
Reason for recall
Units device head descended unexpectedly
Data sourced from openFDA. This site is unofficial and independent of the FDA.