Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors
Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.
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 a software error that could lead to misinterpretation of images or markers, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Healthcare Inc. is recalling 551 units of the Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3, including model numbers 712020, 712022, and 712082. These digital radiographic systems were distributed worldwide, including in the United States and various foreign countries.
The recall is due to a software defect where images may rotate in the wrong direction when an operator selects a non-default rotation or when a rotation is preset in the examination database. If the operator manually rotates the image back, any programmed electronic side markers may also rotate and end up in the wrong position within the image.
Healthcare facilities using these systems should contact Philips Healthcare Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 551
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)
- Systems with Eleva SW version 2.1.3
Distribution
Distributed nationwide across the United States.
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