—#181040

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183040
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 staff working with the system are informed of the content of this safety notice and place a copy of it with the Instructions for Use. Philips will be replacing the Stand MVS Trolley Cable (459800943703) in all affected systems by a new Stand MVS Trolley Cable that has an improved strain relief design. This action will start by end of April 2020. You will be contacted by a local Philips representative to schedule an appointment to replace the cable. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2020-04-10
Terminated: 2021-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181040. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.