Reported Sep 29, 2021 · Completed
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205…
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?
- EPIQ Diagnostic Ultrasound Systems
Software Versions 5.05.0.1 and 5.0.2
- ModelsEPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
- Lot codes and dates
78 of 78 products
Products covered by this recall Model / number Barcodes Product as published 79512000884838047686EPIQ 5 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391 — 00884838047686US118C1388/ (01)00884838047686(21)US118C1388 — 00884838047686US118C1389/ (01)00884838047686(21)US118C1389 — 00884838047686US119C0516/ (01)00884838047686(21)US119C0516 — 00884838047686US119C0517/ (01)00884838047686(21)US119C0517 — 00884838047686US119C0644/ (01)00884838047686(21)US119C0644 — 00884838047686US121C0839/ (01)00884838047686(21)US121C0839 — 00884838047686US219C0823/ (01)00884838047686(21)US219C0823 — 00884838047686US219C0949/ (01)00884838047686(21)US219C0949 — 00884838047686US319C0210/ (01)00884838047686(21)US319C0210 — 00884838047686US518C1519/ (01)00884838047686(21)US518C1519 — 00884838047686US518C1528/ (01)00884838047686(21)US518C1528 — 00884838047686US719C0285/ (01)00884838047686(21)US719C0285 — 00884838047686US719C0603/ (01)00884838047686(21)US719C0603 — 00884838047686US918C0543/ (01)00884838047686(21)US918C0543 — 00884838047686US918C1811/ (01)00884838047686(21)US918C1811 — 00884838047686USD18C1243/ (01)00884838047686(21)USD18C1243 795205EPIQ 5C Serial Numbers/UDI Codes US114C0239/ N/A — US114C0240/ N/A — US114C0241/ N/A - Amount recalled
- Total = 10,583 systems (EPIQ and Afiniti)
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
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
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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