Z-1605-2011

Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic...

Name: Z-1605-2011 Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2010-12-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-12-14 / Terminated / root cause: design

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications on 2010-12-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1605-2011
Status: Terminated
Initiated: 2010-12-14
Posted: 2011-03-08
Terminated: 2012-02-28
Recalling firm: Philips North America LLC
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.
Product code: IXL Device, Spot-Film
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code IXL

K010435Class IIPhilips Bv Pulsera/enduraPhilips Medical Systems, Inc. / cleared 2001-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)