Philips Ultrasound Systems Recalled for Patient Data Entry Error
Philips is recalling EPIQ and Affiniti ultrasound systems with software version 4.0 because patient images may be moved to the wrong folder.
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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Philips Ultrasound Inc is recalling 3,146 EPIK and Affiniti ultrasound systems equipped with software version 4.0. The affected models include the EPIK 5G, EPIC 5C, EPIK 5W, EPIK 7G, EPIC 7C, EPIK 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70.
The recall was initiated because there is a potential that the image of one patient could be unexpectedly moved into another patient's folder when a user utilizes the Edit functionality on the Patient Data Entry (PDE) screen. This error could result in incorrect patient records being associated with specific medical images.
The devices were distributed worldwide, including nationwide in the United States (including Puerto Rico) and to various foreign countries. The FDA has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and…
- Manufacturer
- Philips Ultrasound Inc
- Affected units
- 3,146
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)
- All models containing software version 4.0.
Distribution
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