Philips EPIQ Ultrasound Systems Recalled for Control Panel Failure Risk
Philips is recalling 12,080 EPIQ Diagnostic Ultrasound Systems because the control panel arm assembly may break off if subjected to undue force.
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: The recall involves a risk-of-harm product where the control panel can break off, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Ultrasound Inc is recalling 12,080 units of the EPIQ Diagnostic Ultrasound System, including models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, and EPIQ CVxi. The recall was initiated because the control panel arm assembly may have missing or loose screws. If undue force, pressure, or weight is applied to the control panel, the mechanism can fail and break off.
The affected systems were distributed worldwide, including the United States, Puerto Rico, and the Virgin Islands. These diagnostic ultrasound systems are used to assist interventionists and surgeons with image guidance during the treatment of cardiovascular disease, specifically in procedures that utilize both live X-ray and live Echo Guidance.
Healthcare facilities should identify affected units by checking the model designations and serial numbers listed in the official recall notice. Users should contact Philips Ultrasound Inc for instructions on how to address the defect and ensure the safety of the equipment.
The recalled product
- Product
- Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in…
- Manufacturer
- Philips Ultrasound Inc
- Affected units
- 12,080
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 (7)
- Model/System Designations: EPIQ Elite
- EPIQ 5G
- EPIQ 5C
- EPIQ 5W
- EPIQ 7G
- EPIQ 7C
- EPIQ 7W
Distribution
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