Philips Easy Diagnost Eleva DRF Recalled for Image Marker Misinterpretation
Philips Healthcare is recalling 14 Easy Diagnost Eleva DRF units because a mirror icon on images could be misinterpreted as a right lead marker in PACS systems.
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 potential misinterpretation of image markers without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Philips Healthcare Inc. is recalling 14 units of the Phillips Easy Diagnost Eleva DRF, Model Number 706034, used for universal fluoroscopic applications. The recall was initiated because the mirror icon located on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
The affected units were distributed nationwide in the United States, including the states of FL, CA, WA, AZ, NC, KY, DE, and MO. The specific serial numbers involved are 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, and 402409.
Healthcare facilities should verify their inventory against the provided serial numbers and contact Philips Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — Fluoroscopy
- Hazard
- Affected units
- 14
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 (14)
- Serial Numbers 362600
- 362601
- 364209
- 364210
- 375245
- 375850
- 376439
- 384396
- 387492
- 398185
- 399440
- 399621
- 399623
- 402409
Distribution
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