The Recall Desk
HighFDA (Devices)·Z-2010-2019·Announced 2019-07-31

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.

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 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
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.

See all 3 products in this recall →