DX-D600 - DXD Imaging Package
FDA device recall Z-1738-2017 · posted 2017-04-05 · Terminated
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- Reason for recall
- One of the dent markers from the DX-D600 dropped down from the overhead rail.
- Action taken
- On May 2, 2016, an "URGENT FIELD SAFETY NOTICE" letter was either emailed or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment to be sent back. The letter described background information and actions to be taken.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 81 units
- Distribution
- AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada
- Date initiated
- 2016-05-02
- Date posted
- 2017-04-05
- Date terminated
- 2017-04-10
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DX-D 600 (K112670) | Agfa Healthcare N.V. | 2011-10-27 |