Recall Z-1604-2011 ยท IXL Device, Spot-Film
Philips Medical Systems North America Co. Phillips
Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
| Date | Mar 8, 2011 (initiated Dec 14, 2010) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 |
| Quantity | 10 units |
| Distribution | 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. |
| 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 |