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U.S. Department of Health and Human Services

Class 2 Device Recall Simpleware ScanIP Medical; Simpleware ScanIP

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 Class 2 Device Recall Simpleware ScanIP Medical; Simpleware ScanIPsee related information
Date Initiated by FirmJune 04, 2021
Create DateAugust 12, 2021
Recall Status1 Terminated 3 on September 29, 2022
Recall NumberZ-2254-2021
Recall Event ID 88207
510(K)NumberK142779 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSimpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Code Information Affected version/UDI: Simpleware ScanIP Medical; Simpleware ScanIP O-2018.12: 00863520000338, Simpleware ScanIP Medical; Simpleware ScanIP P-2019.09: 00863520000345, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.03: 00863520000369, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.06: 00863520000352, Simpleware ScanIP Medical; Simpleware ScanIP R-2020.09: 00863520000376, Simpleware ScanIP Medical; Simpleware ScanIP R-2021.03: 00863520000383
FEI Number 3011676026
Recalling Firm/
Manufacturer		 Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Bradninch Hall
Castle Street
Exeter United Kingdom
Manufacturer Reason
for Recall		A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionSynopsys sent a "Urgent Field Safety Notice" on June 18, 2021 via E-Mail. In addition to informing consignees about the recall, the firm request consignees take the following actions: 1. The user should stop using Simpleware ScanIP Medical R-2021.03 and earlier versions and immediately upgrade to the latest version (S-2021.06a/S-2021.06) of the software on SolvNetPlus. 2. The user should also uninstall and/or delete previous installers. 3. If this is not immediately possible, the user should always remove all DICOM tags before: " Using the Register datasets tool through the GUI or scripting. " Or applying any image rotation transforms (e.g. align or flip) through the GUI or scripting. This action can be completed by using the DICOM tags tool in the General section of the Home tab. 4. Complete the customer reply form by July 2, 2021 and submit to via Email simpleware-qms@synopsys.com Customer Helpline +44(0)1392 428752 Postal Address: Simpleware Product Group, Synopsys Northern Europe Ltd., Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, UK Web Portal: https://www.synopsys.com/simpleware.html Fax: N/A
Quantity in Commerce6 software's
DistributionUS: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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