Philips recalls Brilliance 64 X-ray scanners (Code 728231) due to potential fastener issues that could cause parts to become loose during use. Affected units may need inspection or repair.
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 64 X-ray scanners because some fasteners might not be tightened properly. If a fastener fails while in use, parts could become loose, potentially causing harm.
The fasteners in the scanner might not be tightened to the correct specification. If a fastener fails during use, parts secured by it could become loose, which might cause harm.
Healthcare facilities using Philips Brilliance 64 X-ray scanners with model code 728231 are most at risk. Patients and staff using these scanners could be affected if the device malfunctions.
Check for the model code 728231 on the scanner. Units with serial numbers starting with 10655 are affected. This recall applies to scanners sold with these identifiers.
Inspect the fasteners to ensure they are tightened to the correct specification.
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification, which could lead to parts becoming loose during use.
The recall does not specify a remedy, so check with Philips Medical Systems for guidance on inspection or repair.
The recall states there is a potential for harm if fasteners fail, but it does not specify the risk of serious injury.
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-0389-2018 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0389-2018 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.
