The Recall Desk
HighFDA (Devices)·Z-1417-2023·Announced 2023-04-26

Philips 2D Perfusion Medical Imaging Software Recalled for Signal Processing Errors

Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.

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 an FDA Class II medical device recall affecting diagnostic imaging software. The technical issues can produce inaccurate diagnostic presentations, which poses a risk to patient care. However, no illnesses or injuries have been reported, and the hazard remains theoretical, warranting High rather than Severe severity.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the 2D Perfusion software used with Allura Xper and Azurion medical imaging systems. Affected software releases include R1.0.x, R1.1.x, R1.2, and R1.2.1. Approximately 549 units have been distributed globally, with 75 units distributed in the United States.

The software contains technical issues related to signal generation and processing. These issues can result in inaccurate presentations of diagnostic imaging data, which may affect the accuracy of clinical diagnoses.

Healthcare providers and diagnostic imaging facilities using the affected 2D Perfusion software versions should be aware of this recall and the potential for inaccurate image presentations.

The recalled product

Product
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic Imaging Software
Hazard

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)

  • 722006
  • 722008
  • 722010
  • 722012
  • 722013
  • 722020
  • 722023
  • 722026
  • 722027 722028
  • 722029
  • 722035
  • 722038
  • 722039
  • 722058
  • 722059
  • 722064
  • 722067 722068
  • 722078
  • 722079
  • 722223

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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 →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · signal processing error

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