Philips Healthcare: Medical Device Recall in 2021 - (Recall #: Z-0240-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ProxiDiagnost N90 is multi-functional general R/F systems.

Product Classification:

Class II

Date Initiated: September 22, 2021

Date Posted: December 1, 2021

Recall Number: Z-0240-2022

Event ID: 89023

Reason for Recall:

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

Status: Ongoing

Product Quantity: 281 in total

Code Information:

ProxiDiagnost N90

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated