Recall Z-1933-2020— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-10, terminated 2021-01-11. It names one FDA 510(k) clearance: K183040. 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.. 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..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-10
- Terminated
- 2021-01-11
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.