—#96793

Product

Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.

FDA product code: IXL — Device, Spot-Film
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected lot / code info: Site Numbers: 548686, 556612, 41416327, 41446303, 41566246, 41585083, 43896129, 45592395, 47198056, and 49736876.

Why it was recalled

The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.

Root cause (FDA determination)

Device Design

Action the firm took

On 01/06/11, Philips sent an URGENT Device Correction Notice, dated 01/05/2011, to their consignees. The consignees were informed that the fixing strap of the Laser Aiming Device Image Intensifier may inadvertently detach when used with BV Libra, BV Endura Rel. 2, and BV Pulsera Rel 2.3 Mobile X-Ray systems. Specifically the draw latch of the fixing strap holding the CBX Laser to the Image Intensified can be accidentally released during a procedure when used with the above Mobile X-Ray systems. While waiting for Philips to implement their corrective action, the consignees are advised to fix the closed latch body of the draw latch to the metal band using a Tie Wrap. Without securing the latch with a Tie Wrap, the device should not be used. The consignees can contact Philips Call Center at 1-800-722-9377, select 5, and reference FCO 71800035 with any questions about this recall.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington, DC.

Timeline

Recall initiated: 2010-12-14
Posted by FDA: 2011-03-08
Terminated: 2012-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.