Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 27, 2012
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
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 i…
Compiled from official public sources by the editorial team.
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Philips Healthcare Inc. recalled Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror i… - a moderate-severity action.
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror i… was recalled by Philips Healthcare Inc. in June 27, 2012. Reason: With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the …. Check the official notice for the remedy. Verify recall #Z-1818-2012 with the FDA Devices before acting.
The recall
Philips Healthcare Inc. issued this moderate-severity FDA Devices recall-With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the ….
- Moderate
- severity level
- 752 units
- affected scope
- Class II
- classification
- June 27, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1818-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1818-2012) was formally reported on June 27, 2012, with the manufacturer initiating the action on May 22, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Healthcare Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 752 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADES…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
752 units
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1818-2012 |
| Date reported | June 27, 2012 |
| Date initiated | May 22, 2012 |
| Recalling firm | Philips Healthcare Inc. |
| Firm location | Andover, MA |
| Affected scope | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1818-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system. Recalled by Philips Healthcare Inc.. Units affected: 752 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1818-2012.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1818-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 27, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.