The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0497-2025·Announced 2024-11-27

Philips Vue PACS Diagnostic Viewer Software Recall for Calculation Errors

Philips is recalling Vue PACS Diagnostic Viewer software versions 12.1.5 to 12.2.8.454 because a defect may cause incorrect ischemic map calculations, potentially leading to misdiagnosis.

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: The recall involves a risk-of-harm product (medical diagnostic software) where misdiagnosis is a potential consequence, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Philips Medical Systems Technologies Ltd. is recalling 2,439 units of the Vue PACS Diagnostic Viewer with Vue PACS client software, model number 1149418. The affected software versions range from 12.1.5 to 12.2.8.454. This product is intended to provide scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions.

The recall is due to a software issue that may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study. These incorrect values may result in misdiagnosis.

The affected systems were distributed nationwide in the US and worldwide in numerous foreign countries. No specific illnesses or injuries have been reported in the source text. Users should contact Philips Medical Systems Technologies Ltd. for information on corrective actions.

The recalled product

Product
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
Manufacturer
Philips Medical Systems Technologies Ltd.
Category
Medical Device — Diagnostic Software
Hazard
Affected units
2,439

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 (20)

  • UDI-DI: (01)00884838100350(11)200221(10)12.2.5
  • (01)00884838100350(11)200812(10)12.2.6.0
  • (01)00884838100350(11)201207(10)12.2.6.100
  • (01)00884838100350(11)210303(10)12.2.6.200
  • (01)00884838100350(11)210518(10)12.2.6.201
  • (01)00884838100350(11)210729(10)12.2.6.300
  • (01)00884838100350(11)210502(10)12.2.8.0
  • (01)00884838100350(11)220112(10)12.2.8.100
  • (01)00884838100350(11)221213(10)12.2.8.200
  • (01)00884838100350(11)230301(10)12.2.8.210
  • (01)00884838100350(11)230320(10)12.2.8.300
  • (01)00884838100350(11)230608(10)12.2.8.310
  • (01)00884838100350(11)230718(10)12.2.8.400
  • (01)00884838100350(11)230810(10)12.2.8.401
  • (01)00884838100350(11)230824(10)12.2.8.317
  • (01)00884838100350(11)231019(10)12.2.8.412
  • (01)00884838100350(11)231108(10)12.2.8.403
  • (01)00884838100350(11)231129(10)12.2.8.413
  • (01)00884838100350(11)231214(10)12.2.8.414
  • (01)00884838100350(11)231204(10)12.2.8.420

Distribution

Distributed nationwide across the United States.

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