Simpleware recalls ScanIP software versions 7.0, 2016.09, M-2017.06, and N-2018.03 due to potential incorrect anatomical labels causing medical imaging errors. Affected users should contact Simpleware for updates.
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
Simpleware is recalling specific versions of its ScanIP software because a bug might cause anatomical labels to show incorrectly. This could lead to mistakes in medical imaging procedures if users misinterpret the labels.
The software has a bug that can display anatomical labels incorrectly. This might cause medical staff to misunderstand image data during procedures like resampling or re-aligning images, potentially leading to errors in surgical planning.
Medical professionals using Simpleware ScanIP software for imaging transfers and surgical planning are most at risk. The recall affects users with specific software versions listed in the notice.
Check if your software version matches the affected versions: 7.0 (released Dec 2014), 2016.09, M-2017.06, or N-2018.03. These versions were sold with specific UDI codes listed in the recall notice.
Identify your ScanIP version by checking the software's version number or UDI code as listed in the recall notice.
Affected versions are ScanIP 7.0 (released Dec 2014), 2016.09, M-2017.06, and N-2018.03 with specific UDI codes.
Contact Simpleware directly for guidance on updates or alternatives, as the recall does not include a specific remedy.
The recall indicates potential errors in medical imaging procedures, but no specific risk of serious injury is mentioned in the notice.
We’ve drafted a message you can send Simpleware to request your refund or repair — edit it as you like.
Subject: Recall Z-2253-2021 — Simpleware Simpleware Hello, I own a Simpleware that is covered by recall Z-2253-2021 from Simpleware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
