Recall Z-1449-2013 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
| Date | Jun 17, 2013 (initiated Jan 16, 2013) |
| Status | Terminated |
| Reason | An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Philips Healthcare issued an Urgent Field Safety Notification on January 11, 2013, to advised users of issued and perform corrective action to the units. Field Service Engineer (FSE) will execute corrections and attach record to IATD file. Your proposed corrective action plan (CAP) for the Bucky Diagnost system involves two mandatory field actions including new testing for sites with missing documentation and correcting the table height measurements for systems where the incorrect measurement procedure was used. You have also revised your IATD document to improve instructions to the field en |
| Quantity | 66 units |
| Distribution | Worldwide Distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945278 | PHILIPS BUCKY DIAGNOST FAMILY Philips Medical Systems North America, Inc., Dec 14, 1994 |