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 Apr 10, 2017). Affected quantity: 81 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 12, 2017
- Initiation Date
- May 2, 2016
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1738-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026