Recall Z-1151-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722
| Date | Feb 16, 2024 (initiated Jan 2, 2024) |
| Status | Open, Classified |
| Reason | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| Root cause | Process design |
| Action | On January 2, 2024, the firm notified affected consignees via" URGENT Medical Device Correction" letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Disk Bay issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be correcte |
| Quantity | 13, 133 (3,408 US; 9,725 ROW) |
| Distribution | Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Af |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |
| K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V., Jun 28, 2013 |
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |
| K161563 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Jul 29, 2016 |
| K162859 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Dec 2, 2016 |
| K163715 | Allura Xper R9 Philips Medical Systems Nederland B.V., Jan 26, 2017 |