The Recall Desk
HighFDA (Devices)·Z-2306-2021·Announced 2021-08-25

Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail

Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.

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: FDA Class II recall involving mechanical failure that could cause musculoskeletal injury. No reported injuries or hospitalizations; per the rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

Philips Ultrasound Inc. is recalling EPIQ ultrasound systems due to a potential failure of the control panel arm swivel lock mechanism.

The swivel lock on the control panel arm can fail, allowing the monitor to swivel or move freely while being positioned or transported. This creates a risk that the unsecured monitor or panel could strike a user or patient, potentially causing musculoskeletal injury.

The recall affects 8,935 EPIQ ultrasound systems manufactured between February 27, 2020, and May 25, 2021. These systems were distributed worldwide, including throughout the United States and to over 50 countries internationally.

Users and healthcare facilities with affected EPIQ systems should contact Philips Ultrasound Inc. for guidance on repair or replacement. Do not use affected systems if the control panel arm swivel lock cannot be confirmed to be functioning properly.

The recalled product

Product
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • swivel-lock-failure
  • musculoskeletal-injury

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 (1)

  • Manufactured Between 2020-02-27 to 2021-05-25

Distribution

Distributed nationwide across the United States.

Related recalls

Same category