The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2253-2021·Announced 2021-08-18

Medical imaging software displays anatomical orientation tags incorrectly

Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device software with a defect affecting anatomical orientation display. No injuries or illnesses have been reported, but incorrect anatomical orientation in surgical planning software creates a risk of operator error affecting patient care.

Plain-English summary

Simpleware ScanIP is medical imaging software designed to transfer imaging information from medical scanners to output files and to support simulation and evaluation of surgical treatment options. A software bug has been identified in the interface and image processing component that causes anatomical orientation tags and labels to display incorrectly.

This issue could result in operator misunderstanding when resampling or realigning image data, potentially leading to errors in the preparation and evaluation of medical images. The affected software versions are ScanIP 7.0, ScanIP 2016.09, ScanIP M-2017.06, and ScanIP N-2018.03, which have been distributed in California, Florida, France, United Kingdom, Germany, and Australia.

Healthcare organizations and practitioners using the affected software versions should contact Simpleware Product Group at SYNOPSYS NORTHERN EUROPE to obtain a corrected version or guidance on verification of image orientation prior to use in clinical or surgical planning.

The recalled product

Product
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Manufacturer
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 2014)
  • Simpleware ScanIP 2016.09: 00863520000307
  • Simpleware ScanIP M-2017.06: 00863520000314
  • Simpleware ScanIP N-2018.03: 00863520000321

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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