Z-0284-2008

Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97...

Name: Z-0284-2008 Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-02-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-02-27 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520 on 2007-02-27. The reason FDA records is "Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0284-2008
Status: Terminated
Initiated: 2007-02-27
Posted: 2008-01-31
Terminated: 2011-02-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520
Product code: KPQ System, Simulation, Radiation Therapy
Reason for recall: Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.
Quantity in commerce: 287 units total, all recalls Z-0281-285-2008
Distribution: Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countries of Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, China, Israel/Palestine, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, UK, and Vietnam.
Product codes and lots: Serial Numbers: 6018, 6001, 6008, 6067, 6037, 6038, 6059, 6041, 6047, 6017, 6027, 6036, 6040, 6050, 1256, 6082, 6056, 6064, 6083, 6034, 6044, 6055, 6058, 6028, 6090, 6105, 2255, 6079, 6089, 6073, 6052, 6077, 6072, and 6066.

Product code KPQ

K946053Class IISimview(tm) 3000Siemens Medical Solutions USA, Inc. / cleared 1995-03-31

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)