FDA recall, , Moderate risk
Philips MultiDiagnost Eleva and Allura Xper Systems
Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch button that may not fully release.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V., based in Best, Netherlands, recalled its Philips MultiDiagnost Eleva and Philips Allura Xper systems on May 18, 2026. The hand switch button may not fully release, potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection. The recall was added to the FDA's Enforcement Report on June 16, 2026, and was distributed in the US and ROW.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Philips MultiDiagnost Eleva
- Lot code
- All codes
Product details
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C;
Model # 722002 for Allura Xper FD10F;
Model # 722003 for Allura Xper FD10;
Model # 722005 for Allura Xper FD10/10;
Model # 722006 for Allura Xper FD20;
Model # 722008 for Allura Xper FD20 Biplane;
Model # 722010 for Allura Xper FD10;
Model # 722011 for Allura Xper FD10/10;
Model # 722012 for Allura Xper FD20;
Model # 722013 for Allura Xper FD20 Biplane;
Model # 722015 for Allura Xper FD20 OR Table;
Model # 722019 for Allura Xper FD10/10 OR Table;
Model # 722020 for Allura Xper FD20 Biplane OR Table;
Model # 722022 for Allura Xper FD10 OR Table;
Model # 722023 for Allura Xper FD20 OR Table;
Model # 722025 for Allura Xper FD20 Biplane OR Table;
Model # 722026 for Allura Xper FD10;
Model # 722027 for Allura Xper FD10/10;
Model # 722028 for Allura Xper FD20;
Model # 722029 for Allura Xper FD20/10;
Model #722033 for Allura Xper FD10 OR Table;
Model #722035 for Allura Xper FD20 OR Table;
Model #722038 for Allura Xper FD20/20;
Model #722039 for Allura Xper FD20/20 OR Table;
Model #722058 for Allura Xper FD20/15;
Model #722059 for Allura Xper FD20/15 OR Table.- Lot code
- All codes
Recall details
- Company began the recall
- Sold in
US and ROW.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99223
- Recall numbers
- Z-2411-2026 to Z-2412-2026
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
