Philips Spectral CT software issue causes image mislabeling
A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.
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: This is a Class II recall of a diagnostic imaging device where the software defect creates a risk of patient misdiagnosis and incorrect treatment. No illnesses or injuries have been reported, and the hazard remains theoretical, placing the severity at High per the rubric criteria.
Plain-English summary
Philips Medical Systems has recalled the Spectral CT on Rails with Software Version 5.1.0.X (model 728334). A software issue causes all captured images to be labeled incorrectly, which may lead to patient misdiagnosis and incorrect treatment.
One unit was distributed in the United States across the following states: Arkansas, Arizona, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Texas, and West Virginia. The device has also been distributed internationally to Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.
The FDA has classified this as a Class II recall. The device is identified by UDI-DI 00884838103627 with serial number 1005. Affected facilities should contact Philips Medical Systems for information on remediation.
The recalled product
- Product
- Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Affected units
- 1
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 (2)
- UDI-DI: 00884838103627
- serial number: 1005.
Distribution
Part of a larger recall action
This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS 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.
See all 2 products in this recall →Related recalls
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