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Terminated

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

FDA Recall Z-0284-2008 · Posted 2008-01-31

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPQ
Date Initiated2007-02-27
Date Terminated2011-02-03
Product Quantity287 units total, all recalls Z-0281-285-2008

Reason for Recall

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K946053SIMVIEW(TM) 3000Siemens Medical Solutions USA, Inc. · 1995-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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