FDA Medical devices recall ·
Philips MultiDiagnost Eleva with the following Model Numbers: Model #… recall
- Recall number
- Z-2411-2026
- Date
- (initiated May 18, 2026)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
Why was it recalled?
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All codes
Distribution
US and ROW.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2411-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.