Philips recalls Ingenuity Core (Code 728321) due to potential loose fasteners causing harm 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 Ingenuity Core x-ray scanners because some fasteners might not be tightened correctly. If these fasteners loosen while the scanner is in use, they could cause harm.
The x-ray scanner's fasteners might not be tightened to the correct specification. If a fastener fails while the scanner is in use, parts could become loose and potentially cause harm.
Healthcare facilities using the Ingenuity Core (Code 728321) x-ray scanners are most at risk. Patients and staff using the equipment could be affected if the scanner malfunctions.
Check for the model code 728321 on the scanner. Units with serial numbers starting with 310094 are affected.
Inspect the scanner for loose fasteners that may need tightening.
The recall states there is a potential for harm if fasteners become loose during use, but it does not specify a risk of serious injury.
Look for the model code 728321 and serial numbers starting with 310094.
The recall does not specify a remedy, so you should check with Philips for guidance.
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-0390-2018 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0390-2018 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.
