Recall Z-1886-2008 ยท IZW Collimator, Automatic, Radiographic
Philips Medical Systems North America Co. Phillips
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.
| Date | Sep 16, 2008 (initiated Feb 7, 2008) |
| Status | Terminated |
| Reason | The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath. |
| Root cause | Device Design |
| 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 |
| Quantity | 709 devices |
| Distribution | Units were distributed nationwide to medical centers and hospitals, including military and VA hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951372 | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) Philips Medical Systems, Inc., May 4, 1995 |