Recall Z-0281-2008 ยท KPQ System, Simulation, Radiation Therapy
Siemens Medical Solutions USA, Inc
Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520
| Date | Jan 31, 2008 (initiated Feb 27, 2007) |
| Status | Terminated |
| Reason | Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient. |
| 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 | 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, Colombi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946053 | SIMVIEW(TM) 3000 Siemens Medical Solutions USA, Inc., Mar 31, 1995 |