The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2483-2021·Announced 2021-09-29

Philips EPIQ Ultrasound Systems Recalled for Software Lock-up Defect

Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a software defect in a medical device that can cause system lock-up during use. While no injuries or hospitalizations have been reported, the defect represents a risk-of-harm situation for a medical diagnostic device that could interrupt patient examinations.

Plain-English summary

Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems, including models EPIQ 5, 5C, 5G, 7, 7C, 7G, CVxi, and CVx with software versions 5.0, 5.0.1, and 5.0.2. Approximately 10,583 systems have been distributed worldwide, including across all U.S. states and territories.

The recall is due to a software defect that can intermittently cause the ultrasound system to lock-up when exiting Review Mode during patient examinations. This malfunction can disrupt the imaging workflow and prevent normal operation of the device during diagnostic procedures.

Affected systems have been distributed globally as well as throughout the United States and its territories. Healthcare facilities using the affected EPIQ ultrasound systems should review this recall notice.

Customers requiring additional information should consult the FDA recall notice Z-2483-2021 or contact Philips Ultrasound Inc directly.

The recalled product

Product
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound Equipment
Hazard
Affected units
10,583

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • US118C1388/ (01)00884838047686(21)US118C1388
  • US118C1389/ (01)00884838047686(21)US118C1389
  • US119C0516/ (01)00884838047686(21)US119C0516
  • US119C0517/ (01)00884838047686(21)US119C0517
  • US119C0644/ (01)00884838047686(21)US119C0644
  • US121C0839/ (01)00884838047686(21)US121C0839
  • US219C0823/ (01)00884838047686(21)US219C0823
  • US219C0949/ (01)00884838047686(21)US219C0949
  • US319C0210/ (01)00884838047686(21)US319C0210
  • US518C1519/ (01)00884838047686(21)US518C1519
  • US518C1528/ (01)00884838047686(21)US518C1528
  • US719C0285/ (01)00884838047686(21)US719C0285
  • US719C0603/ (01)00884838047686(21)US719C0603
  • US918C0543/ (01)00884838047686(21)US918C0543
  • US918C1811/ (01)00884838047686(21)US918C1811
  • USD18C1243/ (01)00884838047686(21)USD18C1243
  • EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A
  • US114C0240/ N/A
  • US114C0241/ N/A
  • US114C0271/ N/A

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips Ultrasound Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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