Philips recalls certain Ingenuity Core 128 x-ray scanners due to potential fastener issues that could cause parts to become loose during use. Affected units have specific serial numbers and 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 specific models of their Ingenuity Core 128 x-ray scanners because some fasteners might not be tightened properly. If these fasteners fail while the scanner is in use, parts could become loose, potentially causing harm.
Certain fasteners in the scanner might not be tightened to the correct specification. If these fasteners fail during use, parts could become loose, which might cause harm to patients or staff.
Healthcare facilities using the recalled Ingenuity Core 128 x-ray scanners are most at risk. Patients and staff using these scanners could be affected if the device malfunctions.
Check for the model code 728323 with serial numbers 320394, 320395, or 336286. The scanner is intended for head and body x-ray imaging.
Verify the serial number on the device matches the affected numbers: 320394, 320395, or 336286.
Philips identified that certain fasteners might not be torqued correctly, which could cause parts to become loose during use and potentially cause harm.
Check the serial number to see if it matches the affected numbers (320394, 320395, or 336286). If it does, stop using it until further instructions are received.
The recall record does not specify a fix or remedy for this issue.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0391-2018 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0391-2018 from Philips Medical Systems. 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.
