Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues
Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.
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. The hazard involves a physical contact risk (detector contacts head holder) and functional failures in a medical device, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,218 units of the BrightView X nuclear imaging system. The device is designed for single or dual detector nuclear imaging and various ECT studies. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall addresses four specific issues: a motion controller problem that stops scans and prevents data image production; a door interlock switch problem that disables CT scans; a condition where detector contacts touch the head holder during Patient Unload; and JETStream software freezing during gated planar scans.
Healthcare facilities and users of the BrightView X system should contact Philips Medical Systems for instructions on how to address these issues. The source text does not specify a remediation method or timeline.
The recalled product
- Product
- 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studi
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Nuclear Imaging
- Affected units
- 1,218
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 11000100
- 11000019
- 11000034
- 11000020
- 11000112
- 11000086
- 11000045
- 11000092
- 11000037
- 11000038
- 11000106
- 11000059
- 11000064
- 11000039
- 11000087
- 11000004
- 11000058
- 11000030
- 11340005
- 11000113
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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