Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 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 brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".
Recall
- Recall Number
- Z-0141-2011
- Event Number
- 49605
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- September 5, 2008
- Posted
- October 25, 2010
- Terminated
- December 7, 2010
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 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 brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".
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
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.
Nationwide distribution.
127 units