FDA Recall Terminated

Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Recall: Z-1886-2008 · Initiated February 7, 2008

Recall

Recall Number: Z-1886-2008
Event Number: 46216
Firm: Philips Medical Systems North America Co. Phillips
FEI Number: 1000524572
Product Code: IZW
Status: Terminated
Root Cause: Device Design
Initiated: February 7, 2008
Posted: September 16, 2008
Terminated: March 8, 2011
Address: 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

Description

Reason

The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.

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

Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals.

Quantity

709 devices