Date Initiated by Firm | February 18, 2014 |
Date Posted | May 13, 2014 |
Recall Status1 |
Terminated 3 on March 06, 2017 |
Recall Number | Z-1553-2014 |
Recall Event ID |
67603 |
510(K)Number | K971418 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb. |
Code Information |
All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | 914-524-2955 |
Manufacturer Reason for Recall | Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling. |
FDA Determined Cause 2 | Device Design |
Action | On February 18, 2014 Siemens Healthcare Diagnostics distributed Urgent Medical Device Correction notices to their customers via courier service (Urgent Medical Device Correction/). Upon receipt of the communication, customers are asked to follow "Actions to be Taken by the Customer". If the cover is unable to stay partially raised, immediately contact your Siemens technical support representative to arrange for a service. Complete and return the Field Correction Effectiveness Check attached to this letter within thirty (30) days by faxing to (302) 631-7597. Customers with questions should contact their Siemens technical support representative. |
Quantity in Commerce | 5,900 units total (1,679 domestically & 4,221 internationally) |
Distribution | Nationwide and internationally |
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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510(K) Database | 510(K)s with Product Code = JJE
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