Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
This recall has been terminated (originally issued March 8, 2011).
- Recall Initiated
- December 14, 2010
- Posted
- March 8, 2011
- Terminated
- February 28, 2012
- Recall Number
- Z-1605-2011
- Quantity
- 214 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Site Numbers: 541558, 543462, 543465, 546516, 546531, 546786, 548972, 549275, 549674, 551422, 551444, 551536, 552246, 552452, 552642, 553590, 554473, 554778, 555172, 555727, 555734, 556193, 556206, 556207, 556887, 556920, 557242, 557528, 557570, 557711, 558004, 558232, 558418, 558531, 558632, 558698, 558867, 558925, 558966, 558967, 559322, 559533, 559655, 559658, 559679, 718093, 718101, 41443721, 41444449, 41444577, 41445484, 41445534, 41445599, 41445718, 41445794, 41445895, 41446243, 41446285, 41566245, 41577033, 41587498, 41611719, 41620935, 41620966, 41621991, 41630562, 41645797, 41657683, 41725782, 41748088, 41748089, 41757996, 41780384, 41781354, 41793882, 41885442, 41898013, 41936644, 41938193, 41957602, 41980506, 41986348, 41986353, 41986793, 41987067, 42028669, 42057341, 42182116, 42451705, 42454796, 42474222, 42474223, 42474572, 42474590, 42474663, 42474665, 42474666, 42485796, 42573106, 42573206, 42573399, 42602299, 42616997, 42624941, 42638526, 42657622, 42672459, 42673598, 42677649, 42678321, 42678333, 42678370, 42792818, 42792938, 42859118, 42861795, 42865605, 42869019, 42878225, 42878264, 42878386, 42878440, 42879150, 42879151, 42879230, 42879779, 42891959, 42943097, 42967767, 42968938, 43121942, 43188697, 43246451, 43443832, 43444160, 43444432, 43627105, 43670825, 43708894, 43721186, 43721760, 43721768, 43901634, 43901635, 43972187, 44038499, 44066851, 44235029, 44267704, 44280799, 44330157, 44331403, 44468017, 44489300, 44618133, 45003856, 45030262, 45142308, 45147848, 45147983, 45149689, 45167263, 45168542, 45170408, 45298834, 45303038, 45354311, 45419191, 45428659, 45428664, 45567407, 45586672, 45613075, 45632498, 45641330, 45641331, 47171051, 47349848, 47403000, 47405559, 47420473, 47420474, 47480674, 47539379, 49025829, 49316313, 49368038, 49521186, 49580142, 49753197, 49755484, 49755485, 49875328, 50093136, 50103844, 50110372, 50230731, 50264654, 50305994, 50467164, 50498513, 50829949, 50829955, 51232777, 51240352, 51240364, 51240371, 51240383, 51240386, 51674316, 51702012, 51834968, 51836826, and 51836851.
Root 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.