Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SmartPerfusion Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to There are technical issues related to signal generation...

Date: February 20, 2023
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly.

Affected Products

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Quantity: 1461 units (236 US, 1225 OUS)

Why Was This Recalled?

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report