Philips recalls Ingenuity TF PET/CT systems with missing mounting hardware in the Gantry Separation Unit, potentially causing safety issues during medical imaging procedures.
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Philips is recalling certain Ingenuity TF PET/CT medical imaging systems because a wire channel in the Gantry Separation Unit may have missing mounting hardware. This could lead to safety risks during medical procedures if the equipment is not properly secured.
The missing mounting hardware in the Gantry Separation Unit could cause the top covers to become loose or dislodged during operation. This might lead to equipment malfunction or safety hazards during medical imaging procedures.
Medical facilities that own or use the recalled Ingenuity TF PET/CT systems are most at risk. Patients undergoing imaging procedures with these systems may be affected if the equipment is not properly secured.
The recalled units are Philips Ingenuity TF PET/CT systems with model number 882442. This specific model was sold by Philips Medical Systems (Cleveland) Inc.
Verify the model number on your Ingenuity TF PET/CT system to confirm if it matches the recalled model 882442.
The recall affects medical facilities using the equipment, not patients directly. Patients may be affected if the equipment is not properly secured during procedures.
The recall record does not specify a remedy for this issue, so medical facilities should contact Philips Medical Systems (Cleveland) Inc for guidance.
Check if your system has the model number 882442, as this is the specific model recalled by Philips Medical Systems (Cleveland) Inc.
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-0522-2018 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-0522-2018 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.
