Home / Recalls / Philips Electronics North America Corporation / Z-0717-2018

Z-0717-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
December 20, 2017
Termination Date
June 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1486

Product Description

Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)

Reason for Recall

Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001 722002 722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013 722015 722023 722035 722020 722029 722038 722039 722058 722059

Other recalls by Philips Electronics North America Corporation

  • Z-0614-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6. (November 15, 2018)
  • Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
  • Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3220-2018 Class II — NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
  • Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
  • Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3215-2018 Class II — INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular i (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)