Recall Z-2404-2010 ยท IXL Device, Spot-Film
Philips Medical Systems North America Co. Phillips
Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
| Date | Sep 13, 2010 (initiated Jan 4, 2008) |
| Status | Terminated |
| Reason | Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path. |
| Root cause | Other |
| Action | On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US. If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees |
| Quantity | 28 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 Philips Medical Systems, Inc., Nov 24, 1992 |