SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution
Medical device recall Z-0786-2014. Published in FDA’s Enforcement Report on Jan 29, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 29, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 7 states named in where it went
- 65 active devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
65 active devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SIMVIEW NT Part number: 5496992 SIMVIEW NT with IDI Part number: 5497016 US Serial numbers: 6019 6029 6032 6035 6068 6080 6001 International serial numbers: 6060 6027 6067 1236 3654 4190 6006 6007 6014 6015 6020 6022 6023 6024 6030 6042…
Every code shown here, 452 characters
SIMVIEW NT Part number: 5496992 SIMVIEW NT with IDI Part number: 5497016 US Serial numbers: 6019 6029 6032 6035 6068 6080 6001 International serial numbers: 6060 6027 6067 1236 3654 4190 6006 6007 6014 6015 6020 6022 6023 6024 6030 6042 6048 6049 6053 6054 6062 6065 6069 6070 6084 6085 6088 6092 6095 6098 6099 6103 6104 6041DEL 6099-1 1256 6017 6028 6034 6036 6041 6044 6047 6050 6052 6055 6056 6058 6066 6072 6073 6079 6082 6083 6089 6090 6093 6105.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Class II Recall - Worldwide Distribution - US Distribution including the states of California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan., and the countries of Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, Portugal, Greece, Bulgaria, Vietnam, Hungary, Italy, Palestinian Ter, Hungary, Jordan, Egypt Poland, Greece, Curacao, St Eus, Malaysia, Egypt, Malaysia, South Africa Turkey, Thailand, Qatar and Iraq.
The states and territories these words name
- California
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- New York
- Pennsylvania
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2013.
- FDA classified it on Jan 17, 2014.
- FDA’s Enforcement Report published it on Jan 29, 2014.
- FDA terminated it on Mar 31, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Martinez, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.