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Recall Observatory FDA recall evidence

Device product

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.

Z-1933-2020

April 10, 2020

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 85473
Status
Terminated
Classification
Class II
Quantity
25 total
Official record key
device-enforcement:Z-1933-2020

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.