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U.S. Department of Health and Human Services

Class 2 Device Recall RadSuite

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  Class 2 Device Recall RadSuite see related information
Date Initiated by Firm January 31, 2016
Date Posted August 23, 2016
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-2627-2016
Recall Event ID 74919
510(K)Number K053281  
Product Classification System, image processing, radiological - Product Code LLZ
Product RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Code Information Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Carol Nakagawa
262-367-0700
Manufacturer Reason
for Recall		 Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
FDA Determined
Cause 2		 Software design
Action Merge Healthcare sent an Urgent Medical Device Recall letter dated January 28, 2016, and via email on January 31, 2013, to all affected customers. the letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. If you have any additional questions call Merge Customer Service at (877) 741-5369. For further questions, please call (262) 367-0700.
Quantity in Commerce 25 sites potentially have the affected versions
Distribution Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.
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 = LLZ and Original Applicant = EMAGEON INC.
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