Reported Apr 26, 2023 · Ongoing
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Philips Medical Systems Nederland B.v.
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 NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
SmartPerfusionrelease R1.0R1.1R1.1.1R1.1.5R1.1.5.1 and R1.1.6
- Lot codes and dates
- UDI(01)00884838088566 SmartPerfusion with
- Allura Xper or Azurion model number
722003722006722008722010722012722013722020722023722026722027 722028722029722035722038722039722058722059722064722067 722068722078722079722223722224722225722226722227 and 722228
- Software license key459801530271 sw key SmartPerfusion
- Amount recalled
- 1461 units (236 US, 1225 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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