Philips recalls Brilliance iCT medical imaging devices with certain fasteners that may not be torqued to specification, risking parts becoming loose during use. Affected units include specific serial numbers and model codes.
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Philips is recalling certain Brilliance iCT medical imaging devices because some fasteners might not be tightened properly. If a fastener fails while the device is in use, parts could become loose, potentially causing harm.
The fasteners in the device may not be tightened to the correct torque level. If a fastener fails during use, parts secured by it could become loose, which might cause harm to patients or staff.
Medical facilities using the Brilliance iCT devices with specific serial numbers are most at risk. Patients and staff using these devices could be affected if the device malfunctions.
Check for the serial numbers 100776-100794 listed in the recall notice. The devices are intended for medical imaging of the head and body using x-ray technology.
Look for the serial numbers 100776 through 100794 on the device or its documentation.
Philips has identified that certain fasteners may not be torqued to specification, which could cause parts to become loose during use and potentially cause harm.
Check the device's serial number to see if it is affected. If it is, contact Philips for further instructions.
The recall states that parts could become loose during use, which may have a potential for harm, but does not specify serious injury in normal use.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0388-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-0388-2018 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
