FDA-Device2026-06-24Class IIPROCESSING DEFECT
Philips MultiDiagnost Eleva X-ray systems recalled for hand switch button malfunction risk
What this means
The hand switch button on certain Philips MultiDiagnost Eleva X-ray imaging systems may not fully release after use. This malfunction could prevent the system from stopping imaging, potentially leading to unintended radiation exposure or extra contrast dye injection.
- If you operate or maintain one of these systems, contact Philips Medical Systems for repair instructions.
- Do not use the affected device until the hand switch button issue is resolved.
The agency's original wording
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
US and ROW.
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2411-2026Want us to check the next one for you?
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