Medical Imaging Software Bug Affects Diagnostic Calculations on Daylight Saving Time Dates
A software bug in IntelePACS causes incorrect diagnostic value calculations on Daylight Saving Time transition dates, risking incorrect patient diagnoses.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard presents a theoretical risk of diagnostic harm through incorrect calculations, matching the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
IntelePACS Image Fusion Module—InteleViewer is a software application that receives digital images and data from various sources. A bug in versions 5-6-1-P23 and later causes the software to calculate Standard Uptake Values (SUV) incorrectly for PET/CT imaging studies performed on Daylight Saving Time transition dates. On all other dates, the software functions correctly. An incorrect SUV calculation may result in an incorrect diagnosis.
Eighty-eight systems are distributed across the United States and internationally in Canada, Australia, and New Zealand.
Healthcare providers using affected IntelePACS systems should contact the manufacturer (INTELERAD MEDICAL SYSTEMS INCORPORATED) for updated software versions. Any diagnostic decisions based on SUV measurements from images processed on Daylight Saving Time transition dates should be reviewed.
The recalled product
- Product
- IntelePACS (Image Fusion Module) - InteleViewer
- Manufacturer
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Affected units
- 88
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: B228INTELEPACS0
- Device Versions: 5-6-1-P23 and later
Distribution
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