Recall record at a glance
| Official record | Z-1280-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems, Inc. |
| Report date | Apr 6, 2016 |
| Recall initiation date | Sep 24, 2014 |
| Quantity | 4180 devices |
| Location | Andover, MA, United States |
Official product description
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0 The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room. FD10 is compatible with specific magnetic navigation systems
Why the product was recalled
Loss of key image functionality due to a bent pedal of the Footswitch.
Distribution information
Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA SOUTH KUWAIT LATVIA LEBANON LIBYA LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVIA MONGOLIA MOROCCO NEPAL NETHERLANDS NETHERLANDS ANT NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PANAMA Papua New Guinea PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUORTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERAT SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TUNISIA TURKEY UKRAINE UNITED ARAB EMI United Arab Emirates UNITED KINGDOM URUGUAY USA UZBEKISTAN VENEZUELA VIETNAM YEMEN GUADELOUPE SYRIAN ARAB REPUBLIC
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
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