AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality imag
FDA device recall Z-1487-2013 · posted 2013-06-06 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Customers could potentially experience intermittent, unintended and illogical movement when using the product.
- Action taken
- Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 104
- Distribution
- Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
- Date initiated
- 2013-05-15
- Date posted
- 2013-06-06
- Date terminated
- 2014-12-31
- 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 100 (K103597) | Agfa Healthcare N.V. | 2011-01-03 |