Recall Z-2254-2021 ยท LLZ System, Image Processing, Radiological
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
| Date | Jun 4, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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 scripti |
| Quantity | 6 software's |
| Distribution | US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142779 | SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED Simpleware , Ltd., Apr 17, 2015 |