The Recall Desk
HighFDA (Devices)·Z-1007-2026·Announced 2026-01-07

[pending] Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF

Pending LLM rewrite. Source: FDA_DEVICE Z-1007-2026.

What this means for you

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: Pending LLM scoring against the rubric.

Plain-English summary

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

The recalled product

Product
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Manufacturer
Philips Ultrasound, LLC

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 (2)

  • Software Version Numbers: 9.0
  • 9.01

Distribution

Distributed nationwide across the United States.