The Recall Desk
HighFDA (Devices)·Z-1272-2024·Announced 2024-03-13

Medical imaging software measurements incorrect in specific cases

FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.

What this means for you

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 medical device recall with no reported illnesses or injuries. The hazard is a measurement calculation error in clinical imaging software that represents a documented risk of harm through diagnostic error, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

FUJIFILM Healthcare Americas Corporation has recalled Synapse PACS Version 7.2.200, a medical imaging software system (PACS) used in healthcare facilities to manage, store, retrieve, and display medical images.

The software contains a measurement calculation error that occurs under specific conditions. When Synapse PACS analyzes Secondary Capture 2D images that lack pixel spacing information in their DICOM headers and combines them with Breast Tomosynthesis series data, the resulting measurements are calculated incorrectly. This measurement inaccuracy could affect the reliability of diagnostic measurements and assessments made using these images.

Twelve units of this software version were distributed in the United States, including Puerto Rico. The software has also been distributed worldwide to Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, United Arab Emirates, and the United Kingdom. Healthcare organizations currently using Synapse PACS Version 7.2.200 should contact FUJIFILM Healthcare Americas Corporation for information about this issue and any available corrective measures, such as software updates or workarounds.

The recalled product

Product
Synapse PACS - Version 7.2.200
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Medical Imaging Software / PACS
Hazard
  • measurement-inaccuracy
  • imaging-software

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 (2)

  • Software Version: 7.2.200
  • UDI: (01)854904006008(10)0702200

Distribution

Distributed nationwide across the United States.

Related recalls

Same category