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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Philips North America, LLC is recalling Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guida due to 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, twi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026