Philips BrightView XCT Medical Device Recalled for Handcontroller Motion Defect
Philips Medical Systems is recalling 427 BrightView XCT devices because a handcontroller issue may cause uncommanded motions or continued motion after buttons are released.
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 medical device with a risk of uncommanded motion, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 427 units of the BrightView XCT, Model Number 882482. The recall is due to a defect in the handcontroller that may result in spontaneous uncommanded motions or continued motion after the buttons have been released.
The affected devices were distributed worldwide and nationwide in the United States. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Consumers and healthcare facilities should contact Philips Medical Systems for instructions on how to address the handcontroller issue. The recall number is Z-2011-2019.
The recalled product
- Product
- BrightView XCT , Model Number 882482
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 427
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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