Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a dia

FDA device recall Z-1886-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

IZW

Quantity affected

709 devices

Distribution

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

Date initiated

2008-02-07

Date posted

2008-09-16

Date terminated

2011-03-08

Location

Bothell, WA

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