SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5… recallZ-1416-2023 · Philips Medical Systems Nederland B.V. · initiated Feb 20, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
FDA root cause category: Software design
What the company is doing
A recall notification letter was issued February 20, 2023. The Urgent Medical Device Correction letter includes the following instructions for the Customer: " Stop using SmartPerfusion and 2D Perfusion. NOTE: This message does not impact (other parts of) the Philips Allura or Azurion systems or other tools within the Interventional Workspot. The Philips Allura and Azurion systems as well as other Interventional Workspot tools may continue to be used. " Place the Urgent Medical Device Correction Letter with the documentation of the system. " Circulate the notice to all users so that they are aware of the product issue. " Return the reply form attached to the Urgent Medical Device Correction letter to Philips to confirm that the users of the system have reviewed and understood it.
Recall details
- Recall number
- Z-1416-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2023
- Posted by the FDA
- Apr 20, 2023
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 1461 units (236 US, 1225 OUS)
- Product code
- OWB
- FDA submissions
- K181966
- Distribution
- Worldwide - US Nationwide distribution.
Product description
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SmartPerfusion SmartPerfusion - 1Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91806).
- Z-1417-2023 · Open, Classified2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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