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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa DXD 600 system

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  Class 2 Device Recall Agfa DXD 600 system see related information
Date Initiated by Firm August 15, 2018
Date Posted September 25, 2018
Recall Status1 Terminated 3 on June 23, 2020
Recall Number Z-3245-2018
Recall Event ID 81046
510(K)Number K112670  
Product Classification System, x-ray, stationary - Product Code KPR
Product DX-D 600

Product Usage:
The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
Code Information Serial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A5430000057 A5430000058 A5430000060 A5430000061 A5430000063 A5430000066 A5430000067 A5430000068 A5430000074 A5430000079 A5430000081 A5430000085 A5430000089 A5430000095 A5430000096 A5430000100 A5430000105 A5430000106 A5430000107 A5430000108 A5430000119 A5430000121 A5430000124 A5430000125 A5430000130 A5430000131 A5430000132 A5430000133 A5430000137 A5430000143 A5430000144 A5430000149 A5430000156 A5430000162 A5430000165 A5430000166 A5430000172 A5430000176 A5430000177 A5430000183 A5430000184 A5430000199 A5430000206 A5430000207 A5430000215 A5430000218 A5430000222 A5430000224 A5430000225 A5430000226 A5430000228 A5430000229 A5430000234 A5430000237 A5430000238 A5430000242 A5430000246 A5430000247 A5430000248 A5430000249 A5430000263 A5430000264 A5430000272 A5430000275 A5430000276 A5430000279 A5430000281 A5430000285 A5430000293 A5430000295 A5430000296 A5430000297 A5430000298 A5430000299 A5430000300 A5430000303 A5430000304 A5430000305 A5430000306 A5430000311 A5430000312 A5430000313 A5430000320 A5430000321 A5430000322 A5430000323 A5430000324 A5430000331 A5430000332 A5430000338 A5430000350 A5430000351 A5430000354 A5430000357 A5430000358 A5430000359 A5430000360 A5430000368 A5430000369 A5430000374 
Recalling Firm/
Manufacturer		 Agfa N.V.
Septestraat 27
Mortsel Belgium
Manufacturer Reason
for Recall		 A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.
FDA Determined
Cause 2		 Component design/selection
Action On August 15, 2018, an "URGENT FIELD SAFETY NOTICE" letter was emailed to the US and Canadian consignees. The letter described the product issue: Breakage of the steel cables that support the equipment to its roof anchor may cause the equipment to fall down and potentially harm the patient, user, or third parties. Actions undertaken by Agfa NV: Soon Agfa NV or its representative will visit your site to do a verification/inspection of your unit related to this topic. Despite the fact that this issue potentially affects older systems with high workload, Agfa NV or its representative will verify/inspect all DX-D 600 systems. Recommended actions to be taken by the customer: If you notice an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement, please notify your Agfa NV Service contact at once. Customers were asked to complete the attached feedback form to confirm receipt.
Quantity in Commerce 108
Distribution Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = AGFA HEALTHCARE N.V.
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