Recall Z-2042-2023— Philips North America Llc

Name: FDA recall Z-2042-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-05-19. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90, Model No. 712034 and 712035. Reason: There is a software login in issue that may prevent the user from logging in..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-19
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K202564 — DigitalDiagnost C90Philips Medical Systems Dmc GmbH·cleared 2020-09-30

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

DigitalDiagnost C90, Model No. 712034 and 712035

Reason for recall

There is a software login in issue that may prevent the user from logging in.

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