Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1177-2024
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