Simpleware recalls specific versions of ScanIP medical software due to potential incorrect anatomical labels, which could lead to errors in image resampling and surgical planning. Affected versions include O-2018.12 through R-2021.03.
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 medical software because a bug causes anatomical labels to display incorrectly. This could lead to errors when doctors resample or re-align medical images, potentially affecting surgical planning.
The software has a bug that displays anatomical labels incorrectly. This could cause doctors to misunderstand image data during resampling or re-alignment steps, leading to potential errors in surgical planning.
Medical professionals using Simpleware ScanIP software for imaging transfers and surgical simulations are most at risk. Patients using the software for treatment planning may also be affected if errors occur.
Check your software version by looking for the version number in the product details. Affected versions include O-2018.12 through R-2021.03 with specific serial numbers listed in the recall notice.
Look for the version number in your software to confirm if it's affected (O-2018.12 through R-2021.03).
The recall is for medical professionals using the software to plan treatments. Patients are not directly affected by the software bug.
Check the version number in your software; affected versions include O-2018.12 through R-2021.03 with specific serial numbers listed in the recall notice.
No, the recall does not require immediate discontinuation. Users should check their version and consider updating if needed.
We’ve drafted a message you can send Simpleware to request your refund or repair — edit it as you like.
Subject: Recall Z-2254-2021 — Simpleware Simpleware Hello, I own a Simpleware that is covered by recall Z-2254-2021 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.
