Open, Classified

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

FDA Recall Z-1152-2024 · Posted 2024-02-16

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recall StatusOpen, Classified

Product CodeOWB

Date Initiated2024-01-02

Product Quantity13, 133 (3,408 US; 9,725 ROW)

Reason for Recall

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Firm Action

On January 2, 2024, the firm notified affected consignees via" URGENT Medical Device Correction" letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Disk Bay issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be corrected. Philips will be replacing the three components in all affected systems. Philips will contact customers to schedule a visit to replace the affected components. If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).

Root Cause

Process design

Distribution Pattern

Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01 K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017-11-22

Official Source

View FDA Recall →

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