Recall archive / FDA device enforcement
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 — FDA record Z-1416-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
- Reason
- There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 1461 units (236 US, 1225 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1416-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)00884838088566 SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software license key: 459801530271 sw key SmartPerfusion |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 26, 2023
- Recall initiation date
- Feb 20, 2023
- Center classification date
- Apr 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.