Recall Z-0140-2011 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: "Philips...Mobile C-Arm systems BV Pulsera".
| Date | Oct 25, 2010 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor |
| Root cause | Component design/selection |
| Action | On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions. |
| Quantity | 1331 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010435 | PHILIPS BV PULSERA/ENDURA Philips Medical Systems, Inc., Mar 12, 2001 |