Recall Z-1933-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
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.
| Date | Apr 10, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On April 10, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the product issue. Customers were asked to do the following: - Ensure that Cabling Check and Connectors Check are performed daily, as indicated in the User Routine Checks Program (section 7.4 of the Instructions for Use provided with the system). - In case the strain relief is lost and/or damage to the cable/connector is identified; stop using the system and contact your Philips local representative so that the cable can be replaced. - Please ensure that all st |
| Quantity | 25 total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183040 | Zenition 70 Philips Medical Systems Nederland B.V., Dec 6, 2018 |