| Class 2 Device Recall Mevasim | |
Date Initiated by Firm | February 27, 2007 |
Date Posted | January 31, 2008 |
Recall Status1 |
Terminated 3 on February 03, 2011 |
Recall Number | Z-0285-2008 |
Recall Event ID |
45495 |
Product Classification |
Stimulation Radiation Therapy System - Product Code KPQ
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Product | Si emans Evansi, with patient table, Part No: 44 81 586, and without patient table Part No: 44-81-669; Siemens Medical Solutions USA, Concord, CA 94520 |
Code Information |
All Serial Numbers (1182 and higher): 1501, 1516, 1213, 1225, 1200, 1518, 1201, 1520, 1246, 1228, 1197, 1202, 1224, 1231, 1191, 1184, and 1506, "MEVASIM", Serial Numbers (1182 and higher): 1204, 1192, 1216, 1502, 1230, 1220, 1209, 1233, 1510, 1241, 1194, 1514, 1523, 1212, 1222, 1252, 2012, 2010-335-217, 1249, 4000296842, S1144, 01069H400, 1503, 1517, 1251, 1238, 1274, 1509, and 1519 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact | 925-246-8407 |
Manufacturer Reason for Recall | Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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