Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.
What this means for you
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: The recall involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips North America LLC is recalling 62 units of the Philips Medical Systems Spectral CT 7500, Software V5.2.x (Product Code 728333). The affected devices were distributed in the U.S. and U.S. Territories.
The recall is issued because the Bolus tracking scan application may crash with a system error message. If this occurs, Bolus Tracker shots may continue to occur even if the contrast threshold is reached, potentially resulting in the patient receiving additional radiation.
Healthcare facilities should contact Philips for instructions on how to resolve the software issue. Patients who have undergone scans on these devices should consult their healthcare provider if they have concerns about radiation exposure.
The recalled product
- Product
- Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
- Manufacturer
- Philips North America Llc
- Affected units
- 62
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)
- UDI: (01)00884838101111
Distribution
Distribution scope not specified by the agency.
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