CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-r
FDA device recall Z-1378-2015 · posted 2015-04-03 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- Units device head descended unexpectedly
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MUH
- Quantity affected
- 470 units (127 domestically & 343 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
- Date initiated
- 2015-01-08
- Date posted
- 2015-04-03
- Date terminated
- 2017-04-20
- Location
- Rochester, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CS 8100 3D (K133406) | Trophy | 2014-03-14 |