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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX 4.5, IMPAX 5.0 OT3000 Orthopedic Client, IMPAX 5.0 Orthopedic Client, IMPAX ES for Radio

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 Class 2 Recall
IMPAX 4.5, IMPAX 5.0 OT3000 Orthopedic Client, IMPAX 5.0 Orthopedic Client, IMPAX ES for Radio
see related information
Date Posted July 02, 2008
Recall Status1 Terminated on June 30, 2009
Recall Number Z-1307-2008
Recall Event ID 46813
Premarket Notification
510(K) Number
K022292 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning. AGFA Corp., Greenville, South Carolina 29601
Code Information Hectec MediCAD: ETSAN; VOXAR 3D: L72JO; and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes: 60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453, 60+00021535 and 60+00024519.
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-421-1815
Manufacturer Reason
for Recall
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 2/15/07, AGFA notified their consignees of the situation by sending them "Urgent Medical Device Correction" letters, instructing them on how to work around the problem until the firm was able to install the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgraded software had been installed at all affected sites.
Quantity in Commerce 879 units
Distribution Worldwide Distribution - USA including states of AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, KS, MA, MD, ME, MI, NC, NJ, NV, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA and WA, and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA CORP.
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