The Recall Desk
HighFDA (Devices)·Z-0283-2024·Announced 2023-11-15

Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images

Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.

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: This recall involves a medical device where delayed imaging poses a risk of diagnostic error or missed diagnoses, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported. No illnesses or injuries have been reported, and the hazard is theoretical.

Plain-English summary

Philips Ultrasound, Inc. is recalling 83 EPIQ diagnostic ultrasound systems across seven models (EPIQ 7G, 7C, 7W, 5G, 5W, CVx, and Elite) due to a potential software issue. Systems operating with software version 10.0 may present delayed images instead of real-time images, which could affect the quality of diagnostic imaging during clinical use.

The affected systems have been distributed to clinical sites in 16 US states (Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, Nebraska, Nevada, Ohio, Tennessee, Texas, Utah, and Virginia) and Canada. Specific affected units are identified by model number and serial number in FDA recall notice Z-0283-2024.

Healthcare facilities and clinicians currently using affected systems should contact Philips Ultrasound, Inc. for guidance on remediation or firmware updates. Patients who have undergone diagnostic imaging using these systems should consult their healthcare provider if they have questions about the quality or accuracy of their examination.

The recalled product

Product
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
83

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)

  • Model 795201/UDI:(01)00884838047693/Serial Number: USN16B0579

Distribution

Distributed in 17 states:

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 →

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

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Same hazard · delayed imaging

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