Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon S...
FDA Device Recall #Z-1818-2012 — Class II — May 22, 2012
Recall Summary
| Recall Number | Z-1818-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 22, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Healthcare Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 752 units |
Product Description
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Reason for Recall
With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE
Lot / Code Information
Software release 2.0.2 and 2.0.2SP1 including mirror icon
Other Recalls from Philips Healthcare Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2059-2013 | Class II | Philips Easy Upgrade DR, Code No: 712086 Thi... | Aug 8, 2013 |
| Z-1780-2013 | Class II | Radiohead Access Point 1.4 GHz Radiohead Access... | Jul 8, 2013 |
| Z-1797-2013 | Class II | Philips HeartStart MRx Monitor/Defibrillator, ... | Jun 19, 2013 |
| Z-1964-2013 | Class II | Philips Healthcare MobileDiagnostwDR system. M... | Jun 11, 2013 |
| Z-1189-2013 | Class II | HeartStart MRx Monitor/Defribillator; Product C... | Apr 8, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.