Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
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: FDA Class II medical device recall with no reported illnesses or injuries. Medical imaging equipment constitutes a risk-of-harm product, and the identified software crash represents a reproducible hazard affecting clinical operations. This fits the rubric criterion for high severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling the Spectral CT on Rails, Software Version 5.1.0 (Model 728334), due to a software crash that occurs during clinical operation. When an operator activates CCT Fluoroscopy mode while simultaneously pressing the CCT foot pedal, the system crashes and must be restarted.
One unit with Lot Code 1005 has been distributed to a facility in Minnesota. Operators and clinical engineering staff should avoid simultaneous activation of these two features until Philips North America provides a software update or mitigation.
Facilities using this equipment should contact Philips North America for technical guidance and information regarding software updates or alternative procedures. Any incidents or adverse events associated with this issue should be reported to both Philips and the FDA.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- Manufacturer
- Philips North America
- 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
- Lot Code: 1005
Distribution
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