Philips recalls Allura Xper F010 cardiac imaging systems with potential for ceiling monitor to detach and fall, risking injury to patient and users. Affected units sold 2003-2011.
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 recalls Allura Xper F010 cardiac imaging systems that could have their ceiling-mounted monitor detach and fall, potentially injuring patients, users, or bystanders. This risk exists for systems with the FlexVision Monitor Ceiling Suspension sold between 2003 and May 2011.
The ceiling-mounted monitor suspension could detach from its mounting shaft, causing the monitor to fall to the ground. If the monitor falls, it could hit patients, staff, or bystanders, potentially causing injury.
Healthcare facilities using Philips Allura Xper F010 systems with the FlexVision Monitor Ceiling Suspension from 2003 to May 2011 are affected. Patients, staff, and others in the imaging area are at risk if the monitor falls.
Check if your Philips Allura Xper F010 system has the FlexVision Monitor Ceiling Suspension. Affected units were sold between 2003 and May 2011 for cardiac imaging applications.
Inspect if your system has the FlexVision Monitor Ceiling Suspension with the actuator shaft.
No, this recall applies only to healthcare facilities using the Allura Xper F010 systems in medical settings.
Check if your Philips Allura Xper F010 system was sold between 2003 and May 2011 with the FlexVision Monitor Ceiling Suspension for cardiac imaging.
The recall does not specify a remedy, so contact Philips directly for guidance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-3227-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-3227-2018 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.
