Reported Feb 28, 2024 · Ongoing
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally
- invasive surgery procedures Models(1) 722221 (2) 722222 (3) 722280
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 72222100884838099203(1) SN: 66 (01)00884838099203(21)66 — 00884838099203SN: 91 (01)00884838099203(21)91 722280008848380992580088483809921000884838099210008848380992100088483809921000884838099210008848380992100088483809921000884838099210008848380992100088483809921000884838103276SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3) 20 (01)00884838103276(21)20 - Amount recalled
- 14 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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