Z-1177-2024Class II

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally...

Name: Z-1177-2024 Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally...
Creator: Philips Medical Systems Nederland B.v.
Published: 2024-02-06
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2024-02-06 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2)... on 2024-02-06. FDA classified it as Class II and gives the reason as "Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1177-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-06
Posted: 2024-02-22
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
FDA root cause: Under Investigation by firm
Action: Philips notified U.S customers by Urgent Medical Device Correction letter on 06-Feb-2024 via certified mailing via United States Postal Service. " Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk, and action to take: Circulate this Letter to all clinical staff and any service personnel that may service the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction Letter with the documentation of the system until Philips implements the correction in your system. " If the Certeray generator fails, please stop using the system and contact the Customer Care Solutions Center. " Place a copy of this Letter in a visible place in the Control and Technical rooms (e.g., posted on the door). " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGTS to correct the problem As a remedy, Philips will replace the Power Inverter in the Azurion generator cabinet in all affected Azurion systems through the implementation of Field Change Order (FCO72200544). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 27 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.
Product codes and lots: OUS (1) Model: 722227 SN: UDI: 75 (01)00884838099227(21)75 122 (01)00884838099227(21)122 131 (01)00884838099227(21)131 132 (01)00884838099227(21)132 165 (01)00884838099227(21)165 116 (01)00884838099227(21)116 136 (01)00884838099227(21)136.' (2) Model: 722228 Serial Number UDI 168 (01)00884838099234(21)168 197 (01)00884838099234(21)197 154 (01)00884838099234(21)154 193 (01)00884838099234(21)193 165 (01)00884838099234(21)165 163 (01)00884838099234(21)163 139 (01)00884838099234(21)139 202 (01)00884838099234(21)202 141 (01)00884838099234(21)141 200 (01)00884838099234(21)200 174 (01)00884838099234(21)174 178 (01)00884838099234(21)178 147 (01)00884838099234(21)147 208 (01)00884838099234(21)208 171 (01)00884838099234(21)171 167 (01)00884838099234(21)167 194 (01)00884838099234(21)194 176 (01)00884838099234(21)176 228 (01)00884838086777(10)2.0.0.10015 161 (01)00884838099234(21)161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1176-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22
Z-1177-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22
Z-1178-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)