The Recall Desk
HighFDA (Devices)·Z-1407-2025·Announced 2025-03-26

Synapse PACS Software incorrect patient age calculation for infants

FUJIFILM's Synapse PACS Software versions 7.4.x incorrectly calculates patient age for infants under 3 months, potentially affecting clinical decisions. 104 units recalled in US and internationally.

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: FDA Class II recall involving a software error in medical imaging systems that could affect clinical decision-making for vulnerable pediatric patients under 3 months. No reported illnesses or injuries have been documented, classifying this as a risk-of-harm product without reported harm.

Plain-English summary

Synapse PACS Software, version 7.4.x, manufactured by FUJIFILM Healthcare Americas Corporation, is being recalled. The software displays incorrect computed patient age in the VX viewer for patients less than 3 months old.

This error could affect clinical decision-making and patient safety, as accurate patient age is essential for pediatric care, including age-based diagnostic protocols and medication dosing. Incorrect age data may be stored in patient medical records.

The recall affects approximately 104 units (69 in the US, 35 internationally) distributed across 30 US states and countries including Australia, Belgium, Brazil, France, Germany, Portugal, and the UK. Affected software versions are 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, and 7.4.200. Healthcare facilities should contact FUJIFILM Healthcare Americas Corporation for guidance on corrective measures.

The recalled product

Product
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Medical Imaging Software
Hazard
  • age-calculation-error
  • patient-data-error

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 (17)

  • Model numbers: Synapse PACS 7.4.000
  • 7.4.001
  • 7.4.010
  • 7.4.100
  • 7.4.110
  • 7.4.200 Software Version Numbers: Synapse PACS 7.4.000
  • UDI: (01)00854904006008(10)0704000
  • Synapse PACS 7.4.001
  • UDI: (01)00854904006008(10)0704001
  • Synapse PACS 7.4.010
  • UDI: (01)00854904006008(10)0704010
  • Synapse PACS 7.4.100
  • UDI: (01)00854904006008(10)0704100
  • Synapse PACS 7.4.110
  • UDI: (01)00854904006008(10)0704110
  • Synapse PACS 7.4.200
  • UDI: (01)00854904006008(10)0704200.

Distribution

Distributed in 30 states:

  • AR
  • AZ
  • CA
  • CO
  • CT
  • FL
  • GA
  • HI
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MN
  • MO
  • MS
  • NC
  • NJ
  • NY
  • OH
  • OK
  • OR
  • TN
  • TX
  • VT
  • WA
  • WI
  • WV
  • WY

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