Recall Z-1416-2023 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
| Date | Apr 20, 2023 (initiated Feb 20, 2023) |
| Status | Open, Classified |
| Reason | There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. |
| Root cause | Software design |
| Action | 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 ar |
| Quantity | 1461 units (236 US, 1225 OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181966 | SmartPerfusion Philips Medical Systems Nederlands B.V., Aug 17, 2018 |