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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista System

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 Class 2 Recall
Dimension Vista System
see related information
Date Posted September 15, 2010
Recall Status1 Terminated on October 25, 2010
Recall Number Z-2423-2010
Recall Event ID 55763
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.
Code Information Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments within the serial number range of B01060900055 through B01090100414R0, excluding B01081100388R0, B01081100389R0, B01081200396R0, B01081200402R0, B01081200403R0, B01081200404R0, B01081200406R0, B01081200408R0, B01081200410R0, B01081200411R0, B01090100412R0, B01090100413R0.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Siemens issued an Urgent Field Safety Notice in May 2010 to customers with information on what to do if the battery leaks, overheats, or vents an odor. Firm also issued a Support Bulletin to field service personnel to inspect and replace affected units.
Quantity in Commerce 228 units
Distribution Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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