Lower riskMedical device recall · FDA · Published June 4, 2021
Simpleware ScanIP Software Recall: Incorrect Anatomical Labels May Cause Errors
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
Take action
Contact the company
📍Recalling firmSimpleware Product Group, SYNOPSYS NORTHERN EUROPEBradninch Hall, Castle Street · Exeter, United Kingdom
“Simpleware ScanIP Software Recall: Incorrect Anatomical Labels May Cause Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62379-simpleware-scanip-software-recall-incorrect-anatomical-labels-may-cause-errors. Based on FDA recall #Z-2253-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2253-2021%22&limit=1).
The FDA announced on June 4, 2021, that Simpleware Product Group and SYNOPSYS NORTHERN EUROPE are recalling Simpleware ScanIP software due to a bug that may display incorrect anatomical orientation tags. This error could cause operator misunderstanding during image data resampling or re-alignment.
How to tell if you have it
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
The hazard
A bug in the interface and image software could result in anatomical orientation tags or labels being displayed incorrectly. This issue may lead to operator misunderstanding and errors during resampling or re-alignment of image data.
Context
GovInfoNow's records show Simpleware has been involved in previous recalls, including the Simpleware ScanIP software recall on June 4, 2021. Other recent recalls of similar products include PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026), Intelerad InteleShare Software Recall (November 18, 2025), and Philips Achieva 3.0T MRI Recalled (August 21, 2026).
How to tell if you have this one
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.
Brand
Simpleware
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Recall number
Product, codes & lots
Quantity
Z-2253-2021
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.; Affected 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
4 softwares
Z-2254-2021
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.; 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
6 software's
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your ScanIP version by checking the software's version number or UDI code as listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2253-2021 (June 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2253-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.