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
|
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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.
|
510(K) Database |
510(K)s with Product Code = LRG and Original Applicant = BAXTER HEALTHCARE CORP.
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