FDA Recall for Philips C9-4 Ultrasound Transducer

FDA Recalls low FDA · · United States

The FDA has announced a voluntary recall of one unit of the Philips C9-4 Ultrasound Transducer to provide clarification on its useful life.

What Happened

Philips Ultrasound, Inc. is initiating a voluntary recall to provide clarification and labeling that defines the useful life of the ultrasound transducers.

Which Products Are Affected

The affected product is the Philips C9-4 Ultrasound Transducer, with Model No. 989605365021 and Serial No. 033DZ4. Only 1 unit is involved, and it was distributed nationwide in the United States.

What You Should Do

Consumers who have the affected product should follow the initial firm notification, which was a letter, for further instructions on this recall.

Why This Matters

This recall addresses the need for clear labeling on the useful life of medical devices, helping to ensure proper use and safety in healthcare settings.

Source

FDA Recall Notice Z-1619-2026

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
The FDA has announced a voluntary recall of one unit of the Philips C9-4 Ultrasound Transducer to provide clarification on its useful life.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.