Recalls / —
—#198920
Product
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K181966
- Affected lot / code info
- 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
Why it was recalled
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Distribution
- Distribution pattern
- Worldwide - US Nationwide distribution.
Timeline
- Recall initiated
- 2023-02-20
- Posted by FDA
- 2023-04-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #198920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.