Recall Z-0416-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
| Date | Nov 19, 2021 |
| Status | Terminated |
| Reason | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention. |
| Root cause | Other |
| Action | Philips issued Medical Device Correction letter to US consignees on 19-Nov-2021. Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Move the MCS with a 7th or 8th monitor only before or after a procedure. " Do not position the MCS above the patient/sterile field during the procedure. " Place this Field Safety Notice with the system documentation until your system has been fixed. " Circulate this notice to all users of this device so they are aware of the product issues. " Return the attac |
| Quantity | USA: 5 systems R.O.W.: 15 systems |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| 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 |
| 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 |