Philips BrightView X Handcontroller Recall for Uncommanded Motion Risk
Philips Medical Systems is recalling 117 BrightView X devices because a handcontroller issue may cause spontaneous or continued motion.
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: The recall is classified as FDA Class II, and the hazard involves uncommanded motion of a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 117 units of the BrightView X, Model Number 882478. The recall is due to an issue with the handcontroller that may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
The affected devices were distributed worldwide and nationwide in the US. The recall covers specific serial numbers listed in the official FDA record Z-2010-2019.
Healthcare facilities and users should check their device serial numbers against the list provided by the FDA or the manufacturer. If a device is affected, users should follow the instructions provided by Philips Medical Systems for repair or replacement.
The recalled product
- Product
- BrightView X , Model Number 882478
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 117
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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