The Recall Desk
HighFDA (Devices)·Z-2009-2019·Announced 2019-07-31

Philips BrightView SPECT Recalled for Uncommanded Handcontroller Motion

Philips Medical Systems is recalling 696 BrightView SPECT units because the handcontroller may move spontaneously or continue moving 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 is classified as FDA Class II, and the hazard involves uncommanded motion of a medical device which poses a risk of harm, but no injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 696 units of the BrightView SPECT, Model Number 882480. The recall is due to a defect in the handcontroller that may result in spontaneous uncommanded motions or continued motion after the buttons were released.

The affected units 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 resolve the issue with the handcontroller.

The recalled product

Product
BrightView SPECT, Model Number 882480
Affected units
696

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 →