The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1416-2023·Announced 2023-04-26

Philips SmartPerfusion Cardiac Imaging Software Recalled for Signal Processing Errors

Philips recalls SmartPerfusion cardiac imaging software for technical issues in signal generation and processing that can produce inaccurate diagnostic output.

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: FDA Class II recall involving a risk-of-harm medical device where signal processing errors can produce inaccurate diagnostic output in cardiac imaging. However, no injuries or illnesses have been reported, placing this at the high-severity threshold for unproven hazards.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling SmartPerfusion cardiac imaging software (versions R1.0 through R1.1.6) for technical issues in signal generation and processing that can cause inaccurate output displays.

Approximately 1461 units have been distributed globally: 236 in the United States and 1225 outside the United States. The software is used with Allura Xper or Azurion cardiac imaging systems.

The FDA classified this as a Class II recall. No injuries or illnesses have been reported in connection with this issue.

The recalled product

Product
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Cardiac 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.

See all →

Same hazard · inaccurate imaging

See all →

Similar recalls