FDA-Device2026-06-24Class IIPROCESSING DEFECT
Philips MultiDiagnost Eleva X-ray systems recalled for hand switch button malfunction risk
OTHERNationwide distribution
Philips MultiDiagnost Eleva X-ray systems recalled for hand switch malfunction
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.
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
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-2411-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-06-24Philips Allura Xper imaging systems recalled for hand switch button malfunction risk
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
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