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Terminated

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.

FDA Recall Z-1801-2020 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2020-03-05
Date Terminated2022-09-09
Product Quantity162 units

Reason for Recall

No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..

Firm Action

The firm, Philips, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter to the US and an "URGENT-Field Safety Notice" letter to the OUS (foreign countries) dated 2/26/20 on 3/5/2020 to all consignees by certified mail. These letters to all users explained that no torque was specified for the screws that connect the gearbox and the mounting flange within the C-arm roll motor assembly. A low torque could cause stress on the system and result in a loosening of the screws. If this occurs, the C-arm could rotate freely and uncontrolled movement could cause collision and/or entrapment. Philips asked that all users of the system be informed of the issues and to place a copy of the Field Safety Notice in the Instructions for Use for the system. Philips will exchange the roll motor in all affected systems free of charge, starting in March 2020. A local Philips representative will contact each consignee to schedule the roll motor replacement. If you need any further information or support concerning this issue, please contact your local Philips representative. Technical Support Line: 1-800-722-9377.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Wisconsin. And the following Countries of: Australia, Azerbaijan, Chile, Croatia, Czechoslovakia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea South, Lebanon, Mexico, Netherlands, Norway, Pakistan, Poland, Russian Federate, Senegal, Spain, South Africa, Sweden, Switzerland, Taiwan, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181830Azurion R2.0Philips Medical Systems Nederland B.V. · 2018-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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