SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Reported: April 26, 2023 Initiated: February 20, 2023 #Z-1416-2023
Product Description
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Reason for Recall
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 1461 units (236 US, 1225 OUS)
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Best, N/A
Frequently Asked Questions
What product was recalled? ▼
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 1461 units (236 US, 1225 OUS).
Why was this product recalled? ▼
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1416-2023.
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