Philips North America: Medical Device Recall in 2023 - (Recall #: Z-1589-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CombiDiagnost R90 R1.1

Product Classification:

Class II

Date Initiated: March 3, 2023

Date Posted: May 24, 2023

Recall Number: Z-1589-2023

Event ID: 92333

Reason for Recall:

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Status: Ongoing

Product Quantity: 25 systems in total

Code Information:

REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

FDA Mandated