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Terminated

BrightView XCT , Model Number 882482

FDA Recall Z-2011-2019 · Posted None

Recall StatusTerminated
Product CodeKPS
Date Initiated2019-06-10
Date Terminated2020-07-24
Product Quantity427

Reason for Recall

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

Firm Action

Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use the virtual handcontroller located on the touchscreen monitor attached to the gantry as shown in Figure 3. Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a technical solution addressing the issue upon completion of the investigation. If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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