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Class 2 Device Recall Agfa DXD 600 |
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Date Initiated by Firm |
May 02, 2016 |
Date Posted |
April 05, 2017 |
Recall Status1 |
Terminated 3 on April 10, 2017 |
Recall Number |
Z-1738-2017 |
Recall Event ID |
76840 |
510(K)Number |
K112670
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Product Classification |
System, x-ray, stationary - Product Code KPR
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Product |
DX-D600 - DXD Imaging Package |
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 |
Recalling Firm/ Manufacturer |
AGFA Healthcare Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact |
Cassandra McGowan 864-421-1984
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Manufacturer Reason for Recall |
One of the dent markers from the DX-D600 dropped down from the overhead rail.
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FDA Determined Cause 2 |
Labeling design |
Action |
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. |
Quantity in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = AGFA HEALTHCARE N.V.
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