Date Initiated by Firm |
May 22, 2012 |
Date Posted |
June 15, 2012 |
Recall Status1 |
Terminated 3 on February 24, 2017 |
Recall Number |
Z-1818-2012 |
Recall Event ID |
61926 |
510(K)Number |
K982795
|
Product Classification |
Peripheral electromagnetic field (pemf) to aid wound healing - Product Code MQB
|
Product |
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon
Stationary Fluoroscopic system |
Code Information |
Software release 2.0.2 and 2.0.2SP1 including mirror icon |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
|
For Additional Information Contact |
978-687-1501
|
Manufacturer 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
|
FDA Determined Cause 2 |
Software change control |
Action |
Philips Healthcare issued a Field Safety Notice on 5/22/12 advising users of the error. A software update (Rel 2.1.2) will issue to correct the problem. Contact your local Philips representative. 1-800-722-9377.
For questions regarding this recall call 978-687-1501. |
Quantity in Commerce |
752 units |
Distribution |
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 |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
|