Philips BrightView XCT Upgrade Recalled for Potential Patient Contact
Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.
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 involves a risk-of-harm product where the detector may contact the patient, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling three units of the BrightView XCT Upgrade Model 882454. The recall is due to a software defect in the workflow setup script that may cause the detector to come into contact with the patient during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan.
The affected units were distributed worldwide, including in the United States and numerous international locations. The issue was identified by the firm during its review of the product's software workflow.
Consumers and healthcare facilities should contact Philips Medical Systems (Cleveland) Inc for further information regarding the recall and necessary corrective actions.
The recalled product
- Product
- BrightView XCT Upgrade Model 882454
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 3
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 (3)
- 11000021
- 11000082
- 11000111
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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