FDAFDA · Food and drugs·Recall number Z-1933-2020
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
Published May 20, 2020 · Recall initiated: April 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Worldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
- Lot
- Serial Numbers 35 37 56 20 50 2 7 8 10 12 13 47 67 34 19 31 45 86 30 59 51 21 54
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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