Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascul...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0348-2016.
Monitor Ceiling Suspension system may fall
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0348-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Philips Medical Systems, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0348-2016.
Philips Medical Systems, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Philips Medical Systems, Inc. Recall FAQ
Philips Medical Systems, Inc. is the subject of a medical implants safety report: Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascul.... The notice was published on February 3, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 8 units are potentially affected.