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Simpleware ScanIP medical software. For transfer of… recallZ-2254-2021 · Simpleware Product Group, SYNOPSYS NORTHERN EUROPE · initiated Jun 4, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Simpleware Product Group, SYNOPSYS NORTHERN EUROPE or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software Manufacturing/Software Deployment

What the company is doing

Synopsys 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 [email protected] 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

Recall details

Recall number
Z-2254-2021
Status
Terminated
Initiated by the company
Jun 4, 2021
Recalling firm
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Quantity
6 software's
Product code
LLZ
FDA submissions
K142779
Distribution
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia

Product description

Simpleware 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 (models, lots, serial numbers)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K142779 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88207).

Sources and updates

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