Philips EPIQ Ultrasound Systems Recalled for Inaccurate Doppler Flow Visualization
Philips is recalling EPIQ Diagnostic Ultrasound Systems because the Image Boost feature may cause inaccurate color and Doppler flow visualization when used with specific transducers.
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: The recall involves a medical device where a defect could lead to inaccurate diagnostic information (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Ultrasound Inc is recalling 607 units of EPIQ Diagnostic Ultrasound Systems, including models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx, and EPIQ CVxi. The recall affects systems equipped with software version 7.0. These devices were distributed across 36 U.S. states and 34 countries outside the United States.
The recall was initiated because the manufacturer discovered an issue with the EPIQ Image Boost feature when used with the X8-2t TEE Transducer. If Image Boost is enabled, the color box may not accurately represent fluid flow. Additionally, both Continuous Wave (CW) and Pulsed Wave (PW) Doppler traces may fail to accurately represent fluid flow under these conditions.
Healthcare facilities and users should contact Philips Ultrasound Inc for further instructions on how to address this issue. The source text does not specify a particular consumer action beyond the general recall notification, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-2
- Manufacturer
- Philips Ultrasound Inc
- Affected units
- 607
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 (6)
- All EPIQ Systems with software version 7.0 Model Numbers: EPIQ Elite
- EPIQ 5G
- EPIQ 5C
- EPIQ 7G
- EPIQ 7C
- EPIQ CVx & EPIQ CVxi
Distribution
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