Z-2253-2021Class II

Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and...

Name: Z-2253-2021 Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and...
Creator: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Published: 2021-06-04
License: https://open.fda.gov/license/

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE / initiated 2021-06-04 / Terminated / root cause: software

FDA source

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE began a recall of Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment... on 2021-06-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2253-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-04
Posted: 2021-08-12
Terminated: 2022-09-29
Recalling firm: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Product: Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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 tag: software
FDA 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 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
Quantity in commerce: 4 softwares
Distribution: US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2253-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2254-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code LLZ

K142779Class IIScanip; Scanip: Medical Edition; Scanip: MedSimpleware , Ltd. / cleared 2015-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)