Philips EPIQ 7 Ultrasound System Recalled for Pediatric BSA Calculation Error
Philips is recalling EPIQ 7 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.
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 is classified as FDA Class II, and the defect involves a calculation error in a medical device that could impact patient care, fitting the criteria for a High severity rating where risk of harm exists but no specific injuries are reported in the text.
Plain-English summary
Philips Ultrasound, Inc. is recalling EPIQ 7 Ultrasound Systems equipped with the Pediatric Cardiology option. The affected models include EPIQ 7G, EPIC 7C, and EPIQ 7W, with catalog numbers 795200 and 795201. A total of 2,472 units are affected, with 1,154 units in the United States and 1,318 units distributed internationally.
The recall is due to a software defect where a unit conversion error may occur when the system is set to Metric and weight and/or height is entered. This error can result in the incorrect calculation of the patient's Body Surface Area (BSA). The affected units were distributed nationwide in the US and to various international locations including Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
Healthcare facilities should identify affected units by checking the system codes listed in the FDA recall notice. Users should contact Philips Ultrasound, Inc. for instructions on how to correct the software error. No specific corrective action steps are detailed in the provided source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251…
- Manufacturer
- Philips Ultrasound, Inc.
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 (20)
- US114B0158
- US114B0159
- US114B0161
- US114B0168
- US114B0169
- US114B0171
- US114B0172
- US114B0186
- US114B0223
- US114B0225
- US114B0226
- US114B0227
- US114B0228
- US114B0229
- US114B0268
- US114B0269
- US114B0304
- US114B0305
- US114B0306
- US114B0307
Distribution
Distributed nationwide across the United 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.
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