FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
- Recall number
- Z-1605-2011
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
- Status
- Terminated
- Initiated
- 2010-12-14
- Posted
- 2011-03-08
- Terminated
- 2012-02-28
- 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 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.
- Quantity
- 214 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K010435"]
- PMA numbers
- not on file
- Product code
- IXL
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28