Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors
Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect data display rather than a direct physical injury mechanism. No illnesses or injuries are reported in the source text.
Plain-English summary
Philips Ultrasound Inc is recalling all EPIQ and Affiniti Ultrasound systems, including models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. The recall involves 57,430 units distributed worldwide, including nationwide distribution across the United States.
The manufacturer determined that with certain uncommon workflows, there is potential for incorrect patient data to be displayed and saved into an exam. The issue manifests differently for different versions of software, affecting systems with software versions 1.0, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, and 5.0.1.
The source text does not specify specific consumer actions or remediation steps. Healthcare facilities should monitor for official communications from Philips Ultrasound Inc regarding software updates or corrective actions.
The recalled product
- Product
- All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761…
- Manufacturer
- Philips Ultrasound Inc
- Hazard
- Affected units
- 57,430
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 (12)
- All EPIQ and Affiniti Ultrasound systems with software versions 1.0
- 1.1.x
- 1.2.x
- 1.3.x
- 1.4.x
- 1.5.x
- 1.8.x
- 2.0.x
- 3.0.x
- 4.0.x
- 5.0
- 5.0.1
Distribution
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