Z-1738-2017 Class II Terminated
FDA device recall Z-1738-2017 was initiated by AGFA Healthcare Corp. on May 2, 2016 and is designated Class II. Reason for recall: One of the dent markers from the DX-D600 dropped down from the overhead rail. The recall status is terminated (terminated April 10, 2017). Affected quantity: 81 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- May 2, 2016
- Termination Date
- April 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 units
Product Description
DX-D600 - DXD Imaging Package
Reason for Recall
One of the dent markers from the DX-D600 dropped down from the overhead rail.
Distribution Pattern
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
Code Information
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