The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2254-2021·Announced 2021-08-18

Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display

Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.

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: This is a Class II recall of medical imaging software where the hazard (anatomical orientation mislabeling) is theoretical with no reported injuries or illnesses. Per the rubric, theoretical hazards without reported injuries are scored at most 3.

Plain-English summary

Simpleware ScanIP is medical imaging software designed to transfer imaging data from medical scanners to output files and simulate or evaluate surgical treatment options. The FDA has issued a Class II recall for six versions of the software released between 2018 and 2021 (versions O-2018.12, P-2019.09, Q-2020.03, Q-2020.06, R-2020.09, and R-2021.03).

A software bug has been identified that can cause anatomical orientation tags or labels to display incorrectly. This could lead operators to misunderstand image data and make errors during image resampling or re-alignment procedures.

The software has been distributed in the United States in California and Florida, as well as internationally in France, the United Kingdom, Germany, and Australia. Users of affected software versions should contact Simpleware Product Group, SYNOPSYS NORTHERN EUROPE for updated software or guidance.

The recalled product

Product
Simpleware ScanIP medical 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 — Surgical Planning Software
Hazard
Affected units
6

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 (8)

  • Affected version/UDI: Simpleware ScanIP Medical
  • Simpleware ScanIP O-2018.12: 00863520000338
  • Simpleware ScanIP Medical
  • Simpleware ScanIP P-2019.09: 00863520000345
  • Simpleware ScanIP Q-2020.03: 00863520000369
  • Simpleware ScanIP Q-2020.06: 00863520000352
  • Simpleware ScanIP R-2020.09: 00863520000376
  • Simpleware ScanIP R-2021.03: 00863520000383

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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