Recall StatusTerminated
Date Initiated2008-02-07
Date Terminated2011-03-08
Product Quantity709 devices
Reason for Recall
The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
Firm Action
On 2/7/08, the firm issued an URGENT-DEVICE CORRECTION letter via certified mail to their customers. The letter explains the issue and states that the firm will upgrade the collimator by installing a safety plate to prevent the collimator form dislodging from the stand should the screws become lose. The letter also states, "To avoid the potential risk of the collimator falling from the stand, please test the collimator for being loose. Rock the collimator forwards and backwards by grabbing the sides and gently shaking the unit. Please contact Philips immediately if the collimator is loose and do not use the system until Philips can service the unit." The service representatives will visit the sites and install a safety plate to prevent the collimator from falling should the securing screws become loose.
Contact Sarah Baxter at 425-487-7665 or Philips Call Center at 800-722-9377, #5, #2 if you have questions.
Distribution Pattern
Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.