Philips recalls certain URODiagnost imaging systems due to risk of uncontrolled table rotation during use, potentially causing injury. Affected units have specific serial numbers.
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Philips is recalling specific URODiagnost imaging systems because their table could rotate unexpectedly from :0 to +90 degrees without user control. This poses a risk of serious injury if the table moves while a patient is being imaged.
The tilt actuators in the table could detach and cause the table to rotate rapidly between 0 and +90 degrees. This uncontrolled movement cannot be stopped by the user, potentially causing injury to patients or staff.
Healthcare facilities using the recalled URODiagnost imaging systems are most at risk. Patients undergoing procedures with these systems could be injured if the table rotates unexpectedly.
Check for the system serial number starting with 8141641543718481625960171113215. The product was sold as a multifunctional imaging system for medical procedures.
Immediately cease using the affected URODiagnost imaging system as it poses a risk of uncontrolled table rotation.
The tilt actuators could detach and cause the table to rotate rapidly from 0 to +90 degrees without user control, potentially causing injury.
Check for the system serial number starting with 8141641543718481625960171113215. The product was sold as a multifunctional imaging system for medical procedures.
Immediately stop using it now as the hazard poses a risk of uncontrolled table rotation.
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-1604-2018 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1604-2018 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.
