Philips Brilliance CT Scanner Unintended Gantry Motion Poses Collision Risk
Philips is recalling 630 Brilliance CT Big Bore systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.
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: FDA Class II recall without reported hospitalizations or injuries. The hazard describes a theoretical risk of collision between the gantry/table and operators or patients—a risk-of-harm product where injury has not yet been reported, meeting criteria for Score 3 (High).
Plain-English summary
Philips North America LLC is recalling 630 units of the Philips Brilliance CT Big Bore Computed Tomography X-Ray System, Software Version 4.8.0.10430, due to unintended motion issues in the Interventional Control system.
The unintended motion may cause the gantry or table to collide with the operator or patient, creating a risk of injury. The affected systems include Model Nos. 728242, 728243, and 728244 with numerous serial numbers.
These systems have been distributed worldwide, including throughout the United States and to multiple countries internationally. Healthcare facilities currently operating these devices should contact Philips for additional information about the recall.
The recalled product
- Product
- Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
- Manufacturer
- Philips North America Llc
- Hazard
- unintended-motion
- collision
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 (20)
- Model No. 728242
- 728243
- 728244
- UDI: (01)00884838098725(21)7014
- (01)00884838098725(21)7032
- (01)00884838059450(21)7056
- (01)00884838098725(21)7060
- (01)00884838098725(21)7062
- (01)00884838098725(21)7064
- (01)00884838098725(21)7072
- (01)00884838098725(21)7087
- (01)00884838059450(21)7096
- (01)00884838059450(21)7123
- (01)00884838059450(21)7124
- (01)00884838098725(21)7128
- (01)00884838098725(21)7135
- (01)00884838098725(21)7154
- (01)00884838098725(21)7163
- (01)00884838098725(21)7179
- (01)00884838098725(21)7191
Distribution
Distributed nationwide across the United States.
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