Z-1177-2024 Class II Ongoing
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
— Best, N/A
FDA device recall Z-1177-2024 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on Feb 6, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 28, 2024
- Initiation Date
- Feb 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1177-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.