Reported Nov 27, 2024 · Ongoing

Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to…

Philips Medical Systems Technologies Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems Technologies Ltd. · Matam Building 8/2 · Haifa, N/A · N/A

Is this the product you have?

  • Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454
  • software Model Number1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites
Lot codes and dates

31 of 31 products

Products covered by this recall
#BarcodesProduct as published
100884838100350(01)00884838100350(11)200221(10)12.2.5
200884838100350(01)00884838100350(11)200812(10)12.2.6.0
300884838100350(01)00884838100350(11)201207(10)12.2.6.100
400884838100350(01)00884838100350(11)210303(10)12.2.6.200
500884838100350(01)00884838100350(11)210518(10)12.2.6.201
600884838100350(01)00884838100350(11)210729(10)12.2.6.300
700884838100350(01)00884838100350(11)210502(10)12.2.8.0
800884838100350(01)00884838100350(11)220112(10)12.2.8.100
900884838100350(01)00884838100350(11)221213(10)12.2.8.200
1000884838100350(01)00884838100350(11)230301(10)12.2.8.210
1100884838100350(01)00884838100350(11)230320(10)12.2.8.300
1200884838100350(01)00884838100350(11)230608(10)12.2.8.310
1300884838100350(01)00884838100350(11)230718(10)12.2.8.400
1400884838100350(01)00884838100350(11)230810(10)12.2.8.401
1500884838100350(01)00884838100350(11)230824(10)12.2.8.317
1600884838100350(01)00884838100350(11)231019(10)12.2.8.412
1700884838100350(01)00884838100350(11)231108(10)12.2.8.403
1800884838100350(01)00884838100350(11)231129(10)12.2.8.413
1900884838100350(01)00884838100350(11)231214(10)12.2.8.414
2000884838100350(01)00884838100350(11)231204(10)12.2.8.420
Amount recalled
2439 systems

Where it was sold

  • Nationwide

Why it was recalled

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.