CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital
FDA device recall Z-1377-2015 · 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
- 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
- Date initiated
- 2015-01-08
- Date posted
- 2015-04-03
- Date terminated
- 2017-04-20
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CS 8100 CS 8100 ACCESS (K120975) | Trophy | 2012-06-22 |