Recall Z-0909-2007 ยท IXR Table, Radiographic, Tilting
Philips Medical Systems North America Co. Phillips
Philips Easy Diagnost X-Ray System
| Date | Sep 25, 2007 (initiated Jul 23, 2007) |
| Status | Terminated |
| Reason | Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. |
| Root cause | Other |
| Action | On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using t |
| Quantity | 709 units + 31 units added = 740 |
| Distribution | Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970640 | PHILIPS EASY DIAGNOST Philips Medical Systems North America, Inc., Mar 21, 1997 |