Recall Z-1156-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR
| Date | Feb 16, 2024 (initiated Jan 2, 2024) |
| Status | Open, Classified |
| Reason | Dual In-Line Memory Modules (DIMMs) 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 DIMMs 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 corrected. |
| Quantity | 5,500 (1,681 US; 3,819 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
| K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V., Jun 28, 2013 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V., May 21, 2013 |
| K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., Mar 5, 2014 |
| 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 |