Philips recalls Allura Xper FD2O Biplane systems with specific model codes from 2003 to May 2011 due to risk of monitor detachment and potential injury to patients or users.
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Philips is recalling Allura Xper FD2O Biplane medical imaging systems with System Code 722008 that were sold between 2003 and May 2011. The monitor ceiling suspension could detach, causing the monitor to fall and potentially injuring patients, users, or bystanders.
The monitor ceiling suspension, which holds a large screen monitor, may detach from the actuator rotor shaft. If it detaches, the monitor can fall to the ground, creating a risk of injury to patients, users, or bystanders.
Healthcare providers using the Allura Xper FD2O Biplane systems for cardiac imaging between 2003 and May 2011 are most at risk. Patients and others nearby during procedures could also be affected.
Check if your system has System Code 722008 and was purchased between 2003 and May 2011 for cardiac imaging applications. The monitor ceiling suspension is part of the FlexVision system.
Verify your system's System Code is 722008 and was purchased between 2003 and May 2011 for cardiac imaging.
Reach out to Philips for guidance on next steps, as the recall remedy is not specified in the record.
No, this recall specifically affects Allura Xper FD2O Biplane systems with System Code 722008 sold between 2003 and May 2011 for cardiac imaging.
The monitor could fall to the ground, potentially causing injury to patients, users, or bystanders.
The recall remedy is not specified in the record, so contact Philips for guidance on next steps.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-3224-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-3224-2018 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.
