Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

Class I - Dangerous

🏥 Medical Devices Recalled: December 24, 2020 Philips Ultrasound Diagnostic Equipment Nationwide

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Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256 (01)00884838088658(21)US220B1203 (01)00884838088658(21)US919B0305 (01)00884838088658(21)USN19B1106 (01)00884838088658(21)US220B1587 (01)00884838088658(21)US919B1343 (01)00884838088658(21)USO19B0137 (01)00884838088658(21)USO19B2575 (01)00884838088658(21)US120B0933 (01)00884838088658(21)US619B1530 (01)00884838088658(21)US420B2445 (01)00884838088658(21)US420B2446 (01)00884838088658(21)US520B1252 (01)00884838088658(21)US520B1253 (01)00884838088658(21)US520B1254 (01)00884838088658(21)US620B2080 (01)00884838088658(21)US620B2081 (01)00884838088658(21)US620B2082 (01)00884838088658(21)US619B1796 (01)00884838088658(21)US520B0405 (01)00884838088658(21)US520B0407 (01)00884838088658(21)US520B0408 (01)00884838088658(21)US520B0404 (01)00884838088658(21)US520B0412 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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 Ultrasound Inc
Reason for Recall:: Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

Product Codes/Lot Numbers:

Model/System Designations: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi UDI Codes: (01)00884838088658(21)US120B0832 (01)00884838088658(21)US619B1137 (01)00884838088658(21)US720B0256 (01)00884838088658(21)US220B1203 (01)00884838088658(21)US919B0305 (01)00884838088658(21)USN19B1106 (01)00884838088658(21)US220B1587 (01)00884838088658(21)US919B1343 (01)00884838088658(21)USO19B0137 (01)00884838088658(21)USO19B2575 (01)00884838088658(21)US120B0933 (01)00884838088658(21)US619B1530 (01)00884838088658(21)US420B2445 (01)00884838088658(21)US420B2446 (01)00884838088658(21)US520B1252 (01)00884838088658(21)US520B1253 (01)00884838088658(21)US520B1254 (01)00884838088658(21)US620B2080 (01)00884838088658(21)US620B2081 (01)00884838088658(21)US620B2082 (01)00884838088658(21)US619B1796 (01)00884838088658(21)US520B0405 (01)00884838088658(21)US520B0407 (01)00884838088658(21)US520B0408 (01)00884838088658(21)US520B0404 (01)00884838088658(21)US520B0412 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