Recall Z-1416-2023— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1416-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-20

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-02-20. It names one FDA 510(k) clearance: K181966. Product: SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6. Reason: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-20
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K181966 — SmartPerfusionPhilips Medical Systems Nederlands B.V.·cleared 2018-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.