Recall Z-0897-2011 ยท INQ Table, Powered
Phillips Nuclear Medicine
Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
| Date | Jan 12, 2011 (initiated Jan 26, 2009) |
| Status | Terminated |
| Reason | A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient. |
| Root cause | Process change control |
| Action | The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit |
| Quantity | 2 units |
| Distribution | International distribution only: Mexico and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM Adac Laboratories, Jun 8, 2005 |