Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg
Summary
The FDA issued a Class II for Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, int by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: 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 occ.
Details
Source
Device Recall
External ID
Z-1177-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 27 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-06
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1177-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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