SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
FDA device recall Z-1416-2023 · posted 2023-04-20 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 1461 units (236 US, 1225 OUS)
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2023-02-20
- Date posted
- 2023-04-20
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SmartPerfusion (K181966) | Philips Medical Systems Nederlands B.V. | 2018-08-17 |