Date Initiated by Firm | April 09, 2015 |
Date Posted | September 02, 2016 |
Recall Status1 |
Terminated 3 on August 24, 2017 |
Recall Number | Z-2715-2016 |
Recall Event ID |
74853 |
510(K)Number | K053281 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Merge RadSuite software. Radiological image processing system. |
Code Information |
RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA). |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | 262-367-0700 |
Manufacturer Reason for Recall | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues. |
Quantity in Commerce | 10 sites have the affected software that is configured with the specific conditions listed in Code Information |
Distribution | Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX. |
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 = LLZ
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