CT Scanner Software Bug May Cause Gantry to Move to Wrong Position
Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.
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 injuries or illnesses. It describes a risk-of-harm medical device where injury has not yet been reported, matching the rubric criterion for Score 3.
Plain-English summary
Philips North America is recalling the Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 (Lot Code 1005). The unit was distributed in Minnesota.
When the IVC needle position button on the IVC control box is used during a series of CT scans, the plan box may not move to the operator's desired needle position. This can cause the gantry to move to an unexpected location. As a result, the scan may occur at an incorrect anatomical location, or the gantry's unintended motion could collide with the user or needle.
Facilities using this equipment should stop using the IVC needle position button and contact Philips North America for software updates or device replacement. Separately, Philips has identified a software crash issue when the CCT foot pedal is activated, which is covered under a different recall (RES ID 93363).
The recalled product
- Product
- Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- Manufacturer
- Philips North America
- Category
- Medical Device — CT Scanner
- 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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