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.
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, 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
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- 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.
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