Reported Feb 10, 2021 · Terminated
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W,…
Philips Ultrasound Inc.
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 Ultrasound Inc · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
Philips EPIQ Diagnostic Ultrasound SystemModels EPIQ EliteEPIQ 5GEPIQ 5CEPIQ 5WEPIQ 7GEPIQ 7CEPIQ 7W
- EPIQ CVx & EPIQ CVxi - Product Usagethe 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
- Lot codes and dates
- Model/System Designations
EPIQ EliteEPIQ 5GEPIQ 5CEPIQ 5WEPIQ 7GEPIQ 7CEPIQ 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 (01)00884838088658(21)US620B0625 (01)00884838088658(21)US620B0626 (01)00884838088658(21)US620B0627 (01)00884838088658(21)US620B0628 (01)00884838088658(21)US620B0629 (01)00884838088658(21)US620B0630 (01)00884838088658(21)US720B1295
- Serial Numbers
2,610 of 2,610 codes
US820C0578US119B1417US119B1557US120C0464US319B0073US719B1853US719B1854USN19B2032US819B2075USO19B0691USO19B1741US619B0221US619C0415US220B0520US819C0242US719B2105US719B2106US819C0243US819C1639US819C1640US519B0996US619C0505US819C0501US820B1506US820B1549USN19C1237US720C0111US720C0112US320C1372US420C2439US519B1596US519B1597US520B0086US819C2072US820B1501US820B1502US220C1669US519C1368US219B0988US320C1373US519C0081US819C1783US519B1562US320C1367US919C0241US919C0242US819C1181US919C0313US220B0862US819B1736US819B1737US919C0491US919C0045USN19C1112US220C0472US519C0803US519C0802USN19C0635US220C1665US320C0120
- Model/System Designations
- Amount recalled
- 12,080 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
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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