Recall Z-1377-2015— Carestream Health, Inc.

Name: FDA recall Z-1377-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-08

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: K120975. 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 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 record

K120975 — CS 8100 CS 8100 ACCESSTrophy·cleared 2012-06-22

K-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, 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 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.