FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: 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.
- Recall number
- Z-1377-2015
- Recalling firm
- Carestream Health, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-01-08
- Posted
- 2015-04-03
- Terminated
- 2017-04-20
- Reason
- Units device head descended unexpectedly
- Root cause
- Component design/selection
- Action
- The firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
- Quantity
- 3,110 units (863 domestically & 2,247 internationally)
- Distribution
- Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NV, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and the countries of India and Switzerland.
- Lot, serial or model codes
- All serial numbers of affected devices.
- 510(k) numbers
- ["K120975"]
- PMA numbers
- not on file
- Product code
- MUH
- Firm FEI
- 1317307
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28