Z-1932-2020Class II

Philips Zenition 50, System code 718096 -

Name: Z-1932-2020 Philips Zenition 50, System code 718096 -
Creator: Philips North America, LLC
Published: 2020-04-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-10 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and... on 2020-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1932-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-10
Posted: 2020-05-08
Terminated: 2021-01-11
Recalling firm: Philips North America LLC
Product: Philips Zenition 50, System code 718096 - 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA 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 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
Quantity in commerce: 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.
Product codes and lots: Serial Numbers 17 7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1932-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1932-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08
Z-1933-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code OWB

K183101Class IIZenition 50Philips Medical Systems Nederland B.V. / cleared 2018-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)