DX-D600 - DXD Imaging Package
This recall has been terminated (originally issued April 5, 2017).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- May 2, 2016
- Posted
- April 5, 2017
- Terminated
- April 10, 2017
- Recall Number
- Z-1738-2017
- Quantity
- 81 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
One of the dent markers from the DX-D600 dropped down from the overhead rail.
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
Lot / Code Info
A5430000264, A5430000272, A5430000162, A5430000238, A5430000226, A5430000137, A5430000306, A6430000298, A5430000299, A5430000246, A5430000247, A5430000249, A5430000303, A5430000228, A5430000229, A5430000304, A5430000234, A5430000276, A5430000285, A5430000296, A5430000300, A5430000015, A5430000124, A5430000125, A5430000095, A5430000144, A5430000156, A5430000206, A5430000207, A5430000061, A5430000100, A5430000053, A5430000079, A5430000225, A5430000248, A5430000027, A5430000030, A5430000042, A5430000052, A5430000066, A5430000068, A5430000081, A5430000085, A5430000096, A5430000131, A5430000132, A5430000224, A5430000297, A5430000166, A5430000222, A5430000054, A5430000263, A5430000057, A5430000119, A5430000133, A5430000176, A5430000177, A5430000184, A5430000295, A5430000275, A5430000279, A5430000107, A5430000108, A5430000293, A5430000063, A5430000020, A5430000074, A5430000045, A5430000121, A5430000089, A5430000143, A5430000218, A5430000199, A5430000149, A5430000060, A5430000165, A5430000067, A5430000130, A5430000305, A5430000215, A5430000237, A5430000058, A5430000105, A5430000106, A5430000172, A5430000183, A5430000242, A5430000281
Root Cause
Labeling design
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.