Recall Z-1603-2011
Philips Medical Systems North America Co. Phillips · initiated December 14, 2010
Product
Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral, thoracic, abdominal, peripheral, orthopedic, cardiac, and vascular procedures.
Codes / lots: Site Numbers: 557916, 559018, and 44526163.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1603-2011
- Initiated
- December 14, 2010
- Posted by FDA
- March 8, 2011
- Terminated
- February 28, 2012
- Product code
- IZL – System, X-Ray, Mobile
- Quantity
- 3 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.
- Recalling firm
- Philips Medical Systems North America Co. Phillips, Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1604-2011 | Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and…The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a… | 12/14/2010Terminated |
| Z-1605-2011 | Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic…The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a… | 12/14/2010Terminated |