Recall Z-0276-2024— Philips North America Llc

Name: FDA recall Z-0276-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-09-21. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.. Reason: Potential for units suspended on the ceiling to fail and fall..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-21
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 High Performance, used to acquire, process, store, display and export digital radiographic images.

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

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