Recall Z-2976-2011 ยท IZI System, X-Ray, Angiographic
Philips Healthcare Inc.
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional proced
| Date | Aug 10, 2011 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. |
| Root cause | Software design |
| Action | Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly. Please contact your local Philips representative. For further follow up please call (978 ) 687-1501. |
| Quantity | 1423 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |