The Recall Desk
ModerateFDA (Devices)·Z-0864-2021·Announced 2021-01-20

Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors

Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect data display rather than a direct physical injury mechanism. No illnesses or injuries are reported in the source text.

Plain-English summary

Philips Ultrasound Inc is recalling all EPIQ and Affiniti Ultrasound systems, including models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. The recall involves 57,430 units distributed worldwide, including nationwide distribution across the United States.

The manufacturer determined that with certain uncommon workflows, there is potential for incorrect patient data to be displayed and saved into an exam. The issue manifests differently for different versions of software, affecting systems with software versions 1.0, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, and 5.0.1.

The source text does not specify specific consumer actions or remediation steps. Healthcare facilities should monitor for official communications from Philips Ultrasound Inc regarding software updates or corrective actions.

The recalled product

Product
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-24
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
57,430

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 (12)

  • All EPIQ and Affiniti Ultrasound systems with software versions 1.0
  • 1.1.x
  • 1.2.x
  • 1.3.x
  • 1.4.x
  • 1.5.x
  • 1.8.x
  • 2.0.x
  • 3.0.x
  • 4.0.x
  • 5.0
  • 5.0.1

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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