FDA-Device2022-02-23Class II
Zenition 50, Model #718096
Hazard
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Sold states
Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
Affected count
16 US; 76 ROW
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Zenition 50, Model #718096
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0647-2022More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-06-24Philips MultiDiagnost Eleva X-ray systems recalled for hand switch button malfunction risk
- 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
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