Z-1818-2012Class II

Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary...

Name: Z-1818-2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary...
Creator: Philips Healthcare Inc.
Published: 2012-05-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-22 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system on 2012-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1818-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-06-15
Terminated: 2017-02-24
Recalling firm: Philips North America LLC
Product: Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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
Root cause tag: software
FDA root cause: 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
Product codes and lots: Software release 2.0.2 and 2.0.2SP1 including mirror icon

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1818-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1818-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15

Product code MQB

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)