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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan WalkAway40 plus Instrument and MicroScan Walkaway96 plus

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  Class 2 Device Recall MicroScan WalkAway40 plus Instrument and MicroScan Walkaway96 plus see related information
Date Initiated by Firm June 02, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-1990-2014
Recall Event ID 68524
510(K)Number K911400  
Product Classification Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
Product MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge.

Siemens Healthcare Diagnostics, Inc.
in vitro diagnostic
Code Information WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Jose Untalan
916-374-3031
Manufacturer Reason
for Recall		 Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
FDA Determined
Cause 2		 Component design/selection
Action Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
Quantity in Commerce WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
Distribution Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LRG and Original Applicant = BAXTER HEALTHCARE CORP.
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