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.
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 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.
- Hazard
- inaccurate-imaging
- signal-processing-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 (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.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27