Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed.
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. US: Nationwide Distribution in the states of CA, FLĪnd countries of : France, United Kingdom, Germany, Australiaġ A record in this database is created when a firm initiates a correction or removal action. Postal Address: Simpleware Product Group, Synopsys Northern Europe Ltd., Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, UK
Complete the customer reply form by Jand submit to Helpline +44(0)1392 428752 This action can be completed by using the ͍ICOM tags tool in the General section of the Home tab.Ĥ. align or flip) through the GUI or scripting. " Or applying any image rotation transforms (e.g. " Using the Register datasets tool through the GUI or scripting. If this is not immediately possible, the user should always remove all DICOM tags before: The user should also uninstall and/or delete previous installers.ģ. 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.Ģ. In addition to informing consignees about the recall, the firm request consignees take the following actions:ġ. Synopsys sent a "Urgent Field Safety Notice" on Jvia E-Mail. Software Manufacturing/Software Deployment This could result in operator misunderstanding and errors during resampling or re-alignment of image data Simpleware Product Group, SYNOPSYS NORTHERN EUROPEĪ issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. Simpleware ScanIP software.ğor transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.Īffected version/UDI Simpleware ScanIP 7.0: Created before UDI-DI system (released December 2nd, 2014), Simpleware ScanIP 2016.09: 00863520000307, Simpleware ScanIP M-2017.06: 00863520000314, Simpleware ScanIP N-2018.03: 00863520000321
System, image processing, radiological - Product Code LLZ
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