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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Recalled April 26, 2023 · FDA recall Z-1416-2023 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. · FDA Class II
Units
1461 units (236 US, 1225 OUS)
Sold at
Worldwide - US Nationwide distribution.
Description
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Product
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →